COVID -19Phase 2NCT07408297
Evaluating Safety and Immune Response of Janssen, Moderna, Pfizer/BNT, and Novavax COVID-19 Vaccines for Same and Mixed Boosters in Adolescents and Adults Aged 12-64 With and Without HIV in Kenya, DRC, and Rwanda
A Phase 2 study testing Janssen Ad26COVS1, Pfizer-BioNTech vaccine COVID-19 vaccine and Inactivated Sinopharm or Sinovac COVID-19 vaccine in people with COVID -19 and SARS CoV 2 Infection, run by Victoria Biomedical Research Institute at 1 site in Kenya.
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus that emerged in the human population in Wuhan City, Hubei Province, China in December 2019. As of Jan 2022, there are over 328 million SARS-CoV-2 case worldwide and over 5.54 million deaths as a result of infection with SARS-CoV-2… Read more about this study
- Who is it for?
- Ages 12 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID -19, SARS CoV 2 Infection
- What is being tested?
- Janssen Ad26COVS1, Pfizer-BioNTech vaccine COVID-19 vaccine and Inactivated Sinopharm or Sinovac COVID-19 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,919 participants
- Where
- 1 siteKenya
- Study dates
- 18 May 2022to 27 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1. Adolescent male or female aged ≥ 12 to 17 years at screening and adult male or female aged ≥ 18 to 64 years at screening (inclusive).
- 2. Written informed consent (and assent if adolescent), after review of the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee. For participants who cannot read or write, the consent must be witnessed by a literate third party not involved in study conduct.
- 3. Comply with study procedures, including potential home visits for COVID-19 follow-up.
- 4. Has completed a primary homologous vaccination series at least 3 months prior to enrollment. Vaccinations allowed include:
- a) mRNA (Moderna mRNA-1273 or Pfizer/BNT) - primary series is 2 doses
- b) Adenovector 26 (Janssen Ad26COVS1) - primary series is 1 dose;
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- c) Inactivated whole virus (Sinopharm-BIBP or Sinovac) - primary series is 2 doses;
- 5. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 mIU/mL]) must agree to consistently use an effective method of contraception from enrolment and agree to continue adequate contraception until 12 weeks after vaccination:
- a. Condoms (male or female)
- b. Diaphragm with spermicide
- c. Cervical cap with spermicide
- d. Intrauterine device
- e. Oral or patch contraceptives
- f. Hormonal Contraceptives implants or injection e.g., Norplant®, Depo-Provera®.
- g. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle.
- NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. These procedures and laboratory test results must be confirmed by physical examination, by participant recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure.
- 6. Medically stable at screening, as determined by the investigator (based on review of health status, vital signs, medical history, and targeted physical examination). Acceptable Vital signs as determined by the Principal Investigator or designee.
- 7. Receiving highly active antiretroviral therapy (HAART) and using the same regimen the past 8 weeks before screening. Changes in antiretroviral dosage within 8 weeks prior to entering the study are permitted. In addition, the exchange of pharmacological formulation (e.g., the conventional formulation for combination formulations) is allowed. If regimen has changed then the participant can be reconsidered for inclusion once the 8 weeks has passed.
- 8. An HIV-1 viral load < 1000 copies/mL and/or CD4 Count ≥ 200 cells/mm3 within 3 months before randomization. May be taken during screening or utilize medical testing from clinic.
- 9. Documentation of HIV positivity by HIV rapid test or assay as per the Ministry of Health guidelines in the respective countries.
- Each HIV (-) participant must meet all the following criteria to be enrolled in this study:
- 1. Male or female aged ≥ 18 to 64 years at screening, inclusive.
- 2. Willing and able to give informed consent prior to study enrolment and comply with study procedures, including potential home visits for COVID-19 follow-up.
- 3. Has completed a primary homologous vaccination series at least 3 months prior to enrollment. Vaccinations allowed include:
- a. mRNA (Moderna mRNA-1273 or Pfizer/BNT) - primary series is 2 doses
- b. Adenovector 26 (Janssen Ad26COVS1) - primary series is 1 dose;
- c. Inactivated whole virus (Sinopharm-BIBP or Sinovac) - primary series is 2 doses;
- 4. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 mIU/mL]) must agree to abstain from enrolment and through 3 months after the last vaccination OR agree to consistently use an effective method of contraception from enrolment and through 3 months after the last vaccination:
- a. Condoms (male or female)
- b. Diaphragm with spermicide
- c. Cervical cap with spermicide
- d. Intrauterine device
- e. Oral or patch contraceptives
- f. Hormonal Contraceptives implants or injection e.g., Norplant®, Depo-Provera®.
- g. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle.
- NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. These procedures and laboratory test results must be confirmed by physical examination, by participant recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure.
- 5. Medically stable at screening, as determined by the investigator (based on review of health status, vital signs, medical history, and targeted physical examination). Acceptable vital signs by PI.
- 6. Documentation of negative HIV rapid test (or assay) as per the Ministry of Health guidelines in the respective countries.
Who cannot join
- 1. Use of a heterologous COVID-19 primary series at the platform level (mRNA, Adenovector and inactivated vaccine).
- 2. Use of an extended primary vaccination series or prior booster with any SARS-COV2 vaccine.
- 3. Any subject with prior Adverse Events of Special Interest Relevant to COVID-19 (see table 6).
- 4. Unstable or Severe Chronic disease inclusive of:
- a. Hypertension (elevated blood pressure [SBP>180mmHg or DBP>110mmHg]). Note that participants can be retested once after resting or return on another day for retesting. Participants may also have anti-hypertensive medication adjusted and may be reassessed after at least 2 weeks.
- b. Congestive heart failure (CHF) stage 3 or greater or diagnosed cardiovascular disease that is not controlled using medication in the past 6 months.
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- c. Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbations repeated in the past 2 years. Note: If participant has been stable the last 6 months and are not Gold stage 3 or greater, they may be included.
- d. Asthma stage 4 and/or unstable cases with asthma therapy adjustments in the past that 2 months.
- e. Type 1 or any type 2 diabetes (adult onset) of severe grade by history/medical review or with an HbA1c > 8.5 in the last 6 months.
- f. Chronic kidney disease requiring dialysis or GFR <30 (may use associated creatinine based on age and gender).
- g. Chronic hepatic disease with evidence of hepatic compromise by history/medical review. Includes known Hepatitis B or C.
- h. Chronic or serious neurological diseases (e.g. cerebrovascular disease (including transient ischemic attacks), autoimmune disorders, neurologic deterioration (including dementia), Guillain Barre syndrome).
- i. Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness of severe grade or that is not stable over the past 6 months (at the discretion of the investigator).
- j. HIV Stage III/IV
- 5. Cognitive impairment - congenital or acquired
- 6. A child in care i.e., a child who is in the custody, care or guardianship of a director or a director of adoption.
- 7. Participation in research involving an investigational product (drug/biologic/device) within 30 days prior to first study vaccination and planned participation during this study. Exception is if participant in a follow up safety phase and the investigation product has been given > 6 months previously.
- 8. Prior receipt of an Ebola vaccine i.e., Ad26.ZEBOV/MVA-BN-Filo vaccines.
- 9. Received any other vaccine within 4 weeks prior to first study vaccination or planned vaccination within 4 weeks after study vaccination (including mass vaccination campaigns). Participants may be revaluated after the window has passed.
- 10. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital), excluding HIV. Note: Stable endocrine disorders that have a confirmed autoimmune etiology (e.g., thyroid, pancreatic), including stable diabetes are allowed.
- 11. Chronic administration (>14 continuous days) of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 60 days prior to first study vaccination, excluding HAART. Note: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- 12. Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination, excluding HAART.
- 13. Known disturbance of coagulation (iatrogenic or congenital). Note: The use of low-dose aspirin (≤ 325 mg/day) as prophylaxis is acceptable in dosages consistent with local standards of care, but the use of other platelet aggregation inhibitors, thrombin inhibitors, Factor Xa inhibitors, or warfarin derivatives is exclusionary, regardless of bleeding history, because these imply treatment or prophylaxis of known cardiac or vascular disease.
- 14. Any disease or disorder that would indicate a life expectancy less than 3 years such as active cancer.
- 15. Any known allergies to products contained in the investigational product or latex allergy or any history of anaphylaxis in relation to any previous vaccination.
- 16. Women who are breastfeeding or who are pregnant at the time of screening or plan to become pregnant within the first 12 months of the study.
- 17. A serious adverse event that occurs between screening and randomization. Subjects will not be allowed to be randomized.
- 18. History of alcohol abuse or drug addiction within 2 years prior to the first study vaccination.
- 19. Any condition (other than HIV) that, in the opinion of the investigator, would pose a health risk to the participant if enrolled (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
- 20. Study team member or first-degree relative of any study team member (inclusive of sponsor, and site personnel involved in the study).
- Temporary exclusions:
- 21. Acute respiratory and/or non-respiratory illness or documented temperature of > 38°C in the past 24 hours. Note: Participant may be re-evaluated after symptoms have resolved for at least 3 days.
- 22. Positive RT-PCR SARS-CoV-2 test during screening or at time of randomization. Subject must be SARS-COV-2 symptom free and have a negative test prior to randomization.
- 23. Documented severe SARS-CoV-2 infection in the last 3 months. May be rescreened when this period has passed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centre, Randomized, Double Blind, Phase 2b Trial to Evaluate the Safety and Immunogenicity of Janssen Ad26COVS1 (or mRNA (Moderna mRNA-1273 or Pfizer/BNT) and Novavax NVX-CoV2373 COVID-19 Vaccines for Homologous and Heterologous Boosting in Adolescents and Adults Aged 12 to 64 Years With and Without HIV Infection in 3 African Countries Kenya, Democratic Republic of Congo, and Rwanda.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus that emerged in the human population in Wuhan City, Hubei Province, China in December 2019. As of Jan 2022, there are over 328 million SARS-CoV-2 case worldwide and over 5.54 million deaths as a result of infection with SARS-CoV-2 (COVID-19). According to WHO Situation Report on 17 January 2022, Africa has 7 million confirmed cases with over 160, 804 deaths. The COVID-19 pandemic has caused global suffering, mortality, and severe economic pressures. There is thus a continued urgent global need to develop effective and safe vaccines and drugs to make them available at scale and equitably across all countries including in Africa.
Despite the rapid successes in vaccine development and issuance of WHO Emergency Use Listings (EUL), the WHO SAGE Interim Reports and FDA Emergency Use Authorization (EUA) for COVID-19 vaccine evaluations have reported limitations on safety and efficacy data in certain populations including children and adolescents, pregnant women, and immunocompromised individuals such as those with HIV/AIDS who are at higher risk of severe COVID-19 disease. Africa is especially vulnerable in this respect given the high prevalence of HIV/AIDS in countries such as Kenya where the prevalence is over 20% in some places.
Read more
The risk of recurring new waves of COVID-19 cases caused by Variants of Concern (VOC) exacerbates global public health crisis. A weak immune response to either single or two doses of primary vaccination against SARS-CoV-2 has been observed in immunocompromised population. Emerging data from observational studies consistently show waning immunity to primary vaccination for SARS-CoV-2 mutants, and a decline in vaccine effectiveness against SARS-CoV-2 infection and COVID-19 with time since primary vaccinations. These factors have led to consideration of the potential need for, and optimal timing of, booster doses for vaccinated populations. However, vaccine inequality, lack of availability of the same vaccine product used for primary vaccinations and unpredictable vaccine supply remain a challenge in LMIC. Consideration of heterologous COVID-19 vaccine to allow interchangeability (mix and match) use of vaccine products available in LMIC would therefore allow for programmatic flexibility.
Based on a recent systematic review and meta-regression analysis, across the four WHO EUL COVID-19 vaccines with the most data (i.e., BNT162b2, mRNA 1273, Ad26.COV2.S and ChAdOx1-S [recombinant] vaccine), vaccine effectiveness against severe COVID-19 decreased by about 8% (95% confidence interval (CI): 4-15%) over a period of 6 months in all age groups. In adults above 50 years, vaccine effectiveness against severe disease decreased by about 10% (95% CI: 6 - 15%) over the same period. Vaccine effectiveness against symptomatic disease decreased by 32% (95% CI: 11 - 69%) for those above 50 years of age. For some inactivated vaccines (CoronaVac and COVID-19 vaccine BIBP), WHO has already issued the recommendation for the administration of an additional dose to those aged 60 years or older as part of the primary series to make initial immunity more robust.
The FDA issued a EUA for the Janssen Ad26.COV.S1 COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. In September 2021, both the single dose and 2 dose Janssen COVID-19 vaccine regimens demonstrated high efficacy (79% protection (CI, 77%-80%) for COVID-19-related infections and 81 percent (CI, 79%-84%) for COVID-19-related hospitalizations. vs 94% (CI, 58%-100%) protection against symptomatic COVID-19 in the U.S. respectively. Furthermore, the safety profile of the vaccine remained consistent and generally well-tolerated in the 2 regimens. Finally, when a booster of the Janssen COVID-19 vaccine given 6 months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster.
On June 14, 2021, Novavax reported the results of its PREVENT-19 pivotal Phase 3 trial of the NVX-CoV2373. The results showed an overall vaccine efficacy of 90.4% (95% CI: 82.9 - 94.6) in the US and Mexico. Sequenced data showed a vaccine efficacy was 93.2% (95% CI: 83.9 - 97.1) against Variants of Concern and Variants of Interest which represented 82% of cases. Studies of NVX-CoV2373 with Matrix-M adjuvant have demonstrated an acceptable safety and reactogenicity profile in adults ≥18 years of age. On December 20, 2021, the WHO issued interim recommendations and authorized under its emergency use listing (EUL) procedure, the NVX-CoV2373 COVID-19 vaccine developed by Novavax and Serum Institute of India.
The pivotal phase 3 registration trial of the Moderna mRNA-1273 COVID-19 vaccine was conducted in the United States of America and involved about 30 000 participants aged 18 years or older with no known history of SARS-CoV-2 infection.
- Conditions
- COVID -19, SARS CoV 2 Infection
- Being tested
- Janssen Ad26COVS1, Pfizer-BioNTech vaccine COVID-19 vaccine, Inactivated Sinopharm or Sinovac COVID-19 vaccine
- Keywords
- Mix and match
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Janssen Ad26COVS1Biological
Janssen Ad26COVS1 is formulated to contain recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride.
Pfizer-BioNTech vaccine COVID-19 vaccineBiological
Pfizer-BioNTech COVID-19 vaccine, BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA). BNT162b2 elicits a blunted innate immune sensor activating capacity and thus augments antigen expression.
Inactivated Sinopharm or Sinovac COVID-19 vaccineBiological
Sinopharm's BBIBP-CorV and Sinovac's CoronaVac are inactivated whole-virus COVID-19 vaccines. Both are produced by chemically inactivating (using beta-propiolactone) the whole SARS-CoV-2 virus (strain CN02 or similar) and then adsorbing the inactivated viral particles onto an aluminum hydroxide (alum) adjuvant. This traditional vaccine platform presents the immune system with the entire structural repertoire of the virus including spike, nucleocapsid, and membrane proteins in a non-replicating form, thereby inducing a broad antibody and cellular immune response against multiple viral antigens.
| Study group | Role | What they receive |
|---|---|---|
| Heterologous Novavax Boost | Experimental | Not described Receives: Biological: Janssen Ad26COVS1; Biological: Pfizer-BioNTech vaccine COVID-19 vaccine; Biological: Inactivated Sinopharm or Sinovac COVID-19 vaccine |
| Homologous Janssen Boost | Experimental | Not described Receives: Biological: Janssen Ad26COVS1 |
| Heterologous Janssen Boost | Experimental | Not described Receives: Biological: Pfizer-BioNTech vaccine COVID-19 vaccine; Biological: Inactivated Sinopharm or Sinovac COVID-19 vaccine |
| Homologous mRNA Boost | Experimental | Not described Receives: Biological: Pfizer-BioNTech vaccine COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited Local Adverse Events
Occurrence of solicited local AEs (pain, redness, swelling)
Measured: Within 7 days after booster vaccination
Solicited Systemic Adverse Events
Occurrence of solicited systemic AEs (fever, headache, fatigue)
Measured: Within 7 days after booster vaccination
Incidences of vaccine Related Serious Adverse Events
Incidence of SAEs assessed as related to study vaccination
Measured: Through study completion
Immunogenicity Objective 1: Neutralizing Antibody Titer
GMT of SARS-CoV-2 neutralizing antibodies measured by pVNA
Measured: At Day 28 post-booster
Immunogenicity Objective 2:Anti-Spike IgG Titer
GMT of SARS-CoV-2 spike-specific IgG antibodies measured by ELISA
Measured: At Day 28 post-booster
Immunogenicity Objective 3: Fold Rise in Neutralizing Antibodies
GMFR in neutralizing antibody titers from baseline to Day 28
Measured: Baseline (Day 0) and Day 28
Immunogenicity Objective 4: Fold Rise in Anti-Spike IgG
GMFR in spike-specific IgG titers from baseline to Day 28
Measured: Baseline (Day 0) and Day 28
Secondary outcomes (14)
Incidence of Unsolicited Adverse Events
Number and percentage of participants with unsolicited AEs, severity, and relatedness.
Measured: Through 28 days after booster vaccination.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and percentage of participants with TEAEs, by MedDRA term, severity, and relatedness.
Measured: From Day 0 (booster) to Day 85.
Incidence of Adverse Events of Special Interest (AESIs)
Number and percentage of participants with AESIs
Measured: From Booster (Day 0) through study completion, an average of 1 year
Incidence of All Serious Adverse Events (SAEs)
Number and percentage of participants with any SAE.
Measured: From Day 0 through study completion, an average of 1 year
Heterologous vs. Homologous Boost: Neutralizing Antibody Titer
Geometric Mean Titer (GMT) of serum SARS-CoV-2 neutralizing antibodies, comparing heterologous and homologous boost regimens.
Measured: At Day 28 post-booster.
Heterologous vs. Homologous Boost: Fold Rise in Neutralizing Antibodies
Geometric Mean Fold Rise (GMFR) in neutralizing antibody titers from baseline (Day 0) to Day 28, comparing heterologous and homologous boost regimens.
Measured: Baseline (Day 0) and Day 28 post-booster.
Heterologous vs. Homologous Boost: Anti-Spike IgG Titer
Geometric Mean Titer (GMT) of serum SARS-CoV-2 spike-specific IgG antibodies, comparing heterologous and homologous boost regimens.
Measured: At Day 28 post-booster.
Heterologous vs. Homologous Boost: Fold Rise in Anti-Spike IgG
Geometric Mean Fold Rise (GMFR) in anti-spike IgG antibody titers from baseline (Day 0) to Day 28, comparing heterologous and homologous boost regimens.
Measured: Baseline (Day 0) and Day 28 post-booster.
Durability: Neutralizing Antibody Titer Over Time
Geometric Mean Titer (GMT) of serum SARS-CoV-2 neutralizing antibodies at each scheduled post-boost study visit.
Measured: Day 28, Month 6, Month 12
Durability: Fold Rise in Neutralizing Antibodies Over Time
Geometric Mean Fold Rise (GMFR) in neutralizing antibody titers from baseline at each scheduled post-boost study visit.
Measured: Day 0, Day 28, Month 6, Month 12.
Durability: Anti-Spike IgG Titer Over Time
Geometric Mean Titer (GMT) of serum SARS-CoV-2 spike-specific IgG antibodies at each scheduled post-boost study visit.
Measured: Day 28, Month 6, Month 12
Durability: Fold Rise in Anti-Spike IgG Over Time
Geometric Mean Fold Rise (GMFR) in anti-spike IgG antibody titers from baseline at each scheduled post-boost study visit.
Measured: Day 0, Day 28, Month 6, Month 12.
Mucosal Immunity: Secretory IgA (S-IgA) Titer (Day 28)
Geometric Mean Titer (GMT) of mucosal secretory IgA antibodies against SARS-CoV-2 spike protein.
Measured: At Day 28 post-booster.
Mucosal Immunity: Fold Rise in Secretory IgA (S-IgA)
Geometric Mean Fold Rise (GMFR) in mucosal S-IgA antibody titers from baseline (Day 0) to Day 28.
Measured: Baseline (Day 0) and Day 28 post-booster.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start18 May 2022
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID -19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel with multiple arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,919 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victoria Biomedical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rinda Ubuzima, Rwanda, University of Kinshasa, Coalition for Epidemic Preparedness Innovations
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408297
- Sponsor's protocol ID
- VIBRI COVID-19-001/2021
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Randomized, Double Blind, Phase 2b Trial to Evaluate the Safety and Immunogenicity of Janssen Ad26COVS1 (or mRNA (Moderna mRNA-1273 or Pfizer/BNT) and Novavax NVX-CoV2373 COVID-19 Vaccines for Homologous and Heterologous Boosting in Adolescents and Adults Aged 12 to 64 Years With and Without HIV Infection in 3 African Countries Kenya, Democratic Republic of Congo, and Rwanda.
- ClinicalTrials.gov ID
- NCT07408297
- Acronym / sponsor ID
- VIBRI COVID-19-001/2021
- Conditions
- COVID -19, SARS CoV 2 Infection
- Keywords
- Mix and match
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,919 participants (actual)
- Lead sponsor
- Victoria Biomedical Research InstituteUniversity, hospital or other
- Collaborators
- Rinda Ubuzima, Rwanda, University of Kinshasa, Coalition for Epidemic Preparedness Innovations
- Study start
- 18 May 2022 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus that emerged in the human population in Wuhan City, Hubei Province, China in December 2019. As of Jan 2022, there are over 328 million SARS-CoV-2 case worldwide and over 5.54 million deaths as a result of infection with SARS-CoV-2 (COVID-19). According to WHO Situation Report on 17 January 2022, Africa has 7 million confirmed cases with over 160, 804 deaths. The COVID-19 pandemic has caused global suffering, mortality, and severe economic pressures. There is thus a continued urgent global need to develop effective and safe vaccines and drugs to make them available at scale and equitably across all countries including in Africa.
Despite the rapid successes in vaccine development and issuance of WHO Emergency Use Listings (EUL), the WHO SAGE Interim Reports and FDA Emergency Use Authorization (EUA) for COVID-19 vaccine evaluations have reported limitations on safety and efficacy data in certain populations including children and adolescents, pregnant women, and immunocompromised individuals such as those with HIV/AIDS who are at higher risk of severe COVID-19 disease. Africa is especially vulnerable in this respect given the high prevalence of HIV/AIDS in countries such as Kenya where the prevalence is over 20% in some places.
The risk of recurring new waves of COVID-19 cases caused by Variants of Concern (VOC) exacerbates global public health crisis. A weak immune response to either single or two doses of primary vaccination against SARS-CoV-2 has been observed in immunocompromised population. Emerging data from observational studies consistently show waning immunity to primary vaccination for SARS-CoV-2 mutants, and a decline in vaccine effectiveness against SARS-CoV-2 infection and COVID-19 with time since primary vaccinations. These factors have led to consideration of the potential need for, and optimal timing of, booster doses for vaccinated populations. However, vaccine inequality, lack of availability of the same vaccine product used for primary vaccinations and unpredictable vaccine supply remain a challenge in LMIC. Consideration of heterologous COVID-19 vaccine to allow interchangeability (mix and match) use of vaccine products available in LMIC would therefore allow for programmatic flexibility.
Based on a recent systematic review and meta-regression analysis, across the four WHO EUL COVID-19 vaccines with the most data (i.e., BNT162b2, mRNA 1273, Ad26.COV2.S and ChAdOx1-S [recombinant] vaccine), vaccine effectiveness against severe COVID-19 decreased by about 8% (95% confidence interval (CI): 4-15%) over a period of 6 months in all age groups. In adults above 50 years, vaccine effectiveness against severe disease decreased by about 10% (95% CI: 6 - 15%) over the same period. Vaccine effectiveness against symptomatic disease decreased by 32% (95% CI: 11 - 69%) for those above 50 years of age. For some inactivated vaccines (CoronaVac and COVID-19 vaccine BIBP), WHO has already issued the recommendation for the administration of an additional dose to those aged 60 years or older as part of the primary series to make initial immunity more robust.
The FDA issued a EUA for the Janssen Ad26.COV.S1 COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. In September 2021, both the single dose and 2 dose Janssen COVID-19 vaccine regimens demonstrated high efficacy (79% protection (CI, 77%-80%) for COVID-19-related infections and 81 percent (CI, 79%-84%) for COVID-19-related hospitalizations. vs 94% (CI, 58%-100%) protection against symptomatic COVID-19 in the U.S. respectively. Furthermore, the safety profile of the vaccine remained consistent and generally well-tolerated in the 2 regimens. Finally, when a booster of the Janssen COVID-19 vaccine given 6 months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster.
On June 14, 2021, Novavax reported the results of its PREVENT-19 pivotal Phase 3 trial of the NVX-CoV2373. The results showed an overall vaccine efficacy of 90.4% (95% CI: 82.9 - 94.6) in the US and Mexico. Sequenced data showed a vaccine efficacy was 93.2% (95% CI: 83.9 - 97.1) against Variants of Concern and Variants of Interest which represented 82% of cases. Studies of NVX-CoV2373 with Matrix-M adjuvant have demonstrated an acceptable safety and reactogenicity profile in adults ≥18 years of age. On December 20, 2021, the WHO issued interim recommendations and authorized under its emergency use listing (EUL) procedure, the NVX-CoV2373 COVID-19 vaccine developed by Novavax and Serum Institute of India.
The pivotal phase 3 registration trial of the Moderna mRNA-1273 COVID-19 vaccine was conducted in the United States of America and involved about 30 000 participants aged 18 years or older with no known history of SARS-CoV-2 infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel with multiple arms
| Arm | Type | Receives |
|---|---|---|
| Heterologous Novavax Boost | Experimental | Biological: Janssen Ad26COVS1, Biological: Pfizer-BioNTech vaccine COVID-19 vaccine, Biological: Inactivated Sinopharm or Sinovac COVID-19 vaccine |
| Homologous Janssen Boost | Experimental | Biological: Janssen Ad26COVS1 |
| Heterologous Janssen Boost | Experimental | Biological: Pfizer-BioNTech vaccine COVID-19 vaccine, Biological: Inactivated Sinopharm or Sinovac COVID-19 vaccine |
| Homologous mRNA Boost | Experimental | Biological: Pfizer-BioNTech vaccine COVID-19 vaccine |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (38 listed)
- 1. Adolescent male or female aged ≥ 12 to 17 years at screening and adult male or female aged ≥ 18 to 64 years at screening (inclusive).
- 2. Written informed consent (and assent if adolescent), after review of the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee. For participants who cannot read or write, the consent must be witnessed by a literate third party not involved in study conduct.
- 3. Comply with study procedures, including potential home visits for COVID-19 follow-up.
- 4. Has completed a primary homologous vaccination series at least 3 months prior to enrollment. Vaccinations allowed include:
- a) mRNA (Moderna mRNA-1273 or Pfizer/BNT) - primary series is 2 doses
Key exclusion criteria (34 listed)
- 1. Use of a heterologous COVID-19 primary series at the platform level (mRNA, Adenovector and inactivated vaccine).
- 2. Use of an extended primary vaccination series or prior booster with any SARS-COV2 vaccine.
- 3. Any subject with prior Adverse Events of Special Interest Relevant to COVID-19 (see table 6).
- 4. Unstable or Severe Chronic disease inclusive of:
- a. Hypertension (elevated blood pressure [SBP>180mmHg or DBP>110mmHg]). Note that participants can be retested once after resting or return on another day for retesting. Participants may also have anti-hypertensive medication adjusted and may be reassessed after at least 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Janssen Ad26COVS1Janssen Ad26COVS1 is formulated to contain recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride. | Biological | Heterologous Novavax Boost, Homologous Janssen Boost |
| Pfizer-BioNTech vaccine COVID-19 vaccinePfizer-BioNTech COVID-19 vaccine, BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA). BNT162b2 elicits a blunted innate immune sensor activating capacity and thus augments antigen expression. | Biological | Heterologous Janssen Boost, Heterologous Novavax Boost, Homologous mRNA Boost |
| Inactivated Sinopharm or Sinovac COVID-19 vaccineSinopharm's BBIBP-CorV and Sinovac's CoronaVac are inactivated whole-virus COVID-19 vaccines. Both are produced by chemically inactivating (using beta-propiolactone) the whole SARS-CoV-2 virus (strain CN02 or similar) and then adsorbing the inactivated viral particles onto an aluminum hydroxide (alum) adjuvant. This traditional vaccine platform presents the immune system with the entire structural repertoire of the virus including spike, nucleocapsid, and membrane proteins in a non-replicating form, thereby inducing a broad antibody and cellular immune response against multiple viral antigens. | Biological | Heterologous Janssen Boost, Heterologous Novavax Boost |
Primary outcome
Solicited Local Adverse Events
Time frame: Within 7 days after booster vaccination
Occurrence of solicited local AEs (pain, redness, swelling)
Solicited Systemic Adverse Events
Time frame: Within 7 days after booster vaccination
Occurrence of solicited systemic AEs (fever, headache, fatigue)
Incidences of vaccine Related Serious Adverse Events
Time frame: Through study completion
Incidence of SAEs assessed as related to study vaccination
Immunogenicity Objective 1: Neutralizing Antibody Titer
Time frame: At Day 28 post-booster
GMT of SARS-CoV-2 neutralizing antibodies measured by pVNA
Immunogenicity Objective 2:Anti-Spike IgG Titer
Time frame: At Day 28 post-booster
GMT of SARS-CoV-2 spike-specific IgG antibodies measured by ELISA
Immunogenicity Objective 3: Fold Rise in Neutralizing Antibodies
Time frame: Baseline (Day 0) and Day 28
GMFR in neutralizing antibody titers from baseline to Day 28
Immunogenicity Objective 4: Fold Rise in Anti-Spike IgG
Time frame: Baseline (Day 0) and Day 28
GMFR in spike-specific IgG titers from baseline to Day 28
14 secondary outcomes
Incidence of Unsolicited Adverse Events
Time frame: Through 28 days after booster vaccination.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Day 0 (booster) to Day 85.
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: From Booster (Day 0) through study completion, an average of 1 year
Incidence of All Serious Adverse Events (SAEs)
Time frame: From Day 0 through study completion, an average of 1 year
Heterologous vs. Homologous Boost: Neutralizing Antibody Titer
Time frame: At Day 28 post-booster.
Heterologous vs. Homologous Boost: Fold Rise in Neutralizing Antibodies
Time frame: Baseline (Day 0) and Day 28 post-booster.
Heterologous vs. Homologous Boost: Anti-Spike IgG Titer
Time frame: At Day 28 post-booster.
Heterologous vs. Homologous Boost: Fold Rise in Anti-Spike IgG
Time frame: Baseline (Day 0) and Day 28 post-booster.
Durability: Neutralizing Antibody Titer Over Time
Time frame: Day 28, Month 6, Month 12
Durability: Fold Rise in Neutralizing Antibodies Over Time
Time frame: Day 0, Day 28, Month 6, Month 12.
Durability: Anti-Spike IgG Titer Over Time
Time frame: Day 28, Month 6, Month 12
Durability: Fold Rise in Anti-Spike IgG Over Time
Time frame: Day 0, Day 28, Month 6, Month 12.
Mucosal Immunity: Secretory IgA (S-IgA) Titer (Day 28)
Time frame: At Day 28 post-booster.
Mucosal Immunity: Fold Rise in Secretory IgA (S-IgA)
Time frame: Baseline (Day 0) and Day 28 post-booster.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Janssen Ad26COVS1, Pfizer-BioNTech vaccine COVID-19 vaccine and Inactivated Sinopharm or Sinovac COVID-19 vaccine in people with COVID -19 and SARS CoV 2 Infection, run by Victoria Biomedical Research Institute at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited Local Adverse Events (time frame: Within 7 days after booster vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.