Human Papillomavirus InfectionPhase 3NCT06281119
Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years
A Phase 3 study testing Cervavac as three dose regimen, Cervavac as two dose regimen and Gardasil as three dose regimen in people with Human Papillomavirus Infection, run by Serum Institute of India Pvt. Ltd. at 4 sites in 3 countries.
Trial summary
Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Read more about this study
- Who is it for?
- Ages 15 to 25 years, women only
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Cervavac as three dose regimen, Cervavac as two dose regimen and Gardasil as three dose regimen
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 3 Oct 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 15 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women Living with HIV aged 15-25 years at the time of screening
- Subjects with age 18 years and above, should be willing and able to provide written informed consent while for subjects <18*years of age, parents willing to provide written informed consent and subject is willing to sign written assent form for participation prior to initiating any study related procedure.
- Subject or parent willing to comply with all study requirements.
- Subjects who are determined by medical history, physical examination and clinical judgment of the Investigator to be eligible for inclusion in the study.
- Women of childbearing potential (WOCBP) (sexually active/ ≥18 years of age) must meet all the following criteria:
- Have practiced effective contraception (such as any one of the following: oral, transdermal, injectable or implanted contraceptive; condoms; occlusive cap [diaphragm or cervical vault caps]; spermicidal foam/gel/cream, etc.) or have abstained from all activities that could result in pregnancy from the time of screening up to first vaccine administration (Day 0).
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- Have a negative Urine Pregnancy Test (UPT) at screening and on the day of vaccination (Day 0).
- Have agreed to continue effective contraception during the entire treatment period and for two months after completion of the vaccination series.
- Subject must be asymptomatic (or only have persistent generalized lymphadenopathy) regardless of prior clinical stage.
- If the subjects were currently taking antiretroviral (ARV) therapy, subjects were to be on highly active antiretroviral therapy (HAART), have undetectable viral load reported at least six months prior, and have a CD4+ cell count >350 cells/mm3 at study entry.
- If the subjects are not on HAART, subjects should have a CD4+ cell count > 350 cells/mm3 at study entry.
Who cannot join
- Known history of prior vaccination with HPV vaccine.
- Concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens.
- Current diagnosis or prior history of genital warts or treatment of genital warts.
- Current diagnosis or history of treatment for cervical pre malignancies or malignancies.
- Pregnant females.
- History of any allergic diseases or severe allergic reaction to any agent.
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- Presence of an acute illness and/or fever at the time of vaccination or during the 72 hours prior to the vaccination.
- Presence of active tuberculosis or currently on TB therapy.
- Bleeding diathesis or uncontrolled condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection.
- History of major congenital defects or illness that requires medical therapy, as determined by medical history or clinical assessment.
- History of chronic administration of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study.
- History of receiving a blood transfusion or other blood products in three months prior to screening.
- History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
- History of any cancer, organ transplant or any other immune system disease (other than HIV/AIDs).
- Subject or subject's parent, is or has an immediate family member who is study specific site staff directly involved with this trial.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Kenya2 sites
Centre For Clinical Research, Kemri
Nairobi, 54840-00200
Partners in Health and Research Development (Phrd)
Thika, 19865-00202
Mozambique1 site
Manhiça Health Research Center - Manhiça Foundation (CISM-FM)
Manhiça, 1929
South Africa1 site
Clinical HIV Research Unit (CHRU), Helen Joseph Hospital
Johannesburg, 2092
About this study
Official title: A Phase-3b, Partially Double-blind, Randomized, Multi-country Clinical Study to Evaluate the Immunogenicity,Safety, and Reactogenicity of SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years
Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years.
Read the detailed description
A Phase-3b, partially double-blind, randomized, multi-country study to assess the immunogenicity, safety, and reactogenicity of SIIPL qHPV vaccine in WLWH aged 15-25 years. A total of 450 subjects will be enrolled in the study such that 150 subjects in each group receive either 3-doses of SIIPL qHPV vaccine, 2-doses of SIIPL qHPV vaccine or 3-doses of Gardasil®.
Subjects will be randomized in a 1:1:1 ratio to a 2-dose or 3-dose schedule of SIIPL qHPV vaccine or 3-dose schedule of Gardasil®. This study is designed as a partially double-blind, randomized study with a primary objective to compare the immunogenicity of the 3-dose schedule of SIIPL qHPV vaccine versus a 3-dose schedule of Gardasil®. The secondary objectives include comparison in the immune response between WLWH receiving 2-dose schedule of SIIPL qHPV vaccine and a 3-dose schedule of SIIPL qHPV. The immunogenicity data will be collected up to Month 12 and data at 7-month will be considered for analysis of primary immunogenicity endpoints.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Cervavac as three dose regimen, Cervavac as two dose regimen, Gardasil as three dose regimen
- Keywords
- Cervavac, Quadrivalent, HPV, Vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervavac as three dose regimenBiological
Cervavac manufactured by Serum Institute of India Pvt Ltd administered as three doses at day 0, 60 and 180.
Cervavac as two dose regimenBiological
Cervavac manufactured by Serum Institute of India Pvt Ltd administered as two doses at day 0 and 180.
Gardasil as three dose regimenBiological
Gardasil manufactured by MSD administered as a three doses at day 0,60 and 180.
| Study group | Role | What they receive |
|---|---|---|
| Cervavac administered as three doses | Experimental | Recombinant Quadrivalent Human Papillomavirus (Types 6,11 16, 18) Vaccine manufactured by Serum Institute of India Pvt Ltd administered as three doses at day 0, 60 and 180. Receives: Biological: Cervavac as three dose regimen |
| Cervavac administered as two doses | Experimental | Recombinant Quadrivalent Human Papillomavirus (Types 6,11 16, 18) Vaccine manufactured by Serum Institute of India Pvt Ltd administered as two doses at day 0 and 180. Receives: Biological: Cervavac as two dose regimen |
| Gardasil administered as three doses | Active comparator | Recombinant Quadrivalent Human Papillomavirus (Types 6,11 16, 18) Vaccine manufactured by MSD administered as three doses at day 0, 60 and 180. Receives: Biological: Gardasil as three dose regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titers of anti HPV 16 and 18 IgG antibodies
GMTs of anti HPV 16 and 18 IgG antibodies in WLWH receiving 3 doses of SIIPL qHPV and 3 doses of Gardasil®
Measured: at 1 month after the last dose
Secondary outcomes (3)
Immune response (Geometric mean titers) of anti HPV 6 and 11 IgG antibodies
Geometric mean titers of anti HPV 6 and 11 IgG antibodies in WLWH receiving 3 doses of SIIPL qHPV or Gardasil
Measured: at 1 month after the last dose
Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion
Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion in WLWH receiving 2 doses or 3 doses of SIIPL qHPV or 3 doses of Gardasil
Measured: at 1 month after the last dose
Adverse Events
Incidence, severity, and relationship of local and systemic solicited AEs up to 7 days following each vaccination. Incidence, severity, and relationship of unsolicited AEs from Day 0 through Month 7 and Month 12. Incidence, severity, and relationship of SAEs from Day 0 through Month 7 and Month 12.
Measured: solicited AEs up to 7 days following each vaccination, unsolicited AEs from Day 0 through Month 7 and Month12 and SAEs from Day 0 through Month 7 and Month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start3 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Carla Chibwesha, Principal investigator, Clinical HIV Research Unit, Helen Joseph Hospital, Johannesburg, South AfricaNelly Mugo, Principal investigator, CCR, KEMRI, Nairobi-Kenya & PHRD, Thika-KenyaTacilta Nhampossa, Principal investigator, Manhiça Health Research Center - Manhiça Foundation,Manhiça
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281119
- Sponsor's protocol ID
- SII-qHPV/MC-03
- Status last verified
- Jun 2026
- First submitted
- 20 Feb 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary results for primary and secondary objectives
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-3b, Partially Double-blind, Randomized, Multi-country Clinical Study to Evaluate the Immunogenicity,Safety, and Reactogenicity of SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years
- ClinicalTrials.gov ID
- NCT06281119
- Acronym / sponsor ID
- SII-qHPV/MC-03
- Conditions
- Human Papillomavirus Infection
- Keywords
- Cervavac, Quadrivalent, HPV, Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Feb 2024 (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.
Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years.
Detailed description
A Phase-3b, partially double-blind, randomized, multi-country study to assess the immunogenicity, safety, and reactogenicity of SIIPL qHPV vaccine in WLWH aged 15-25 years. A total of 450 subjects will be enrolled in the study such that 150 subjects in each group receive either 3-doses of SIIPL qHPV vaccine, 2-doses of SIIPL qHPV vaccine or 3-doses of Gardasil®.
Subjects will be randomized in a 1:1:1 ratio to a 2-dose or 3-dose schedule of SIIPL qHPV vaccine or 3-dose schedule of Gardasil®. This study is designed as a partially double-blind, randomized study with a primary objective to compare the immunogenicity of the 3-dose schedule of SIIPL qHPV vaccine versus a 3-dose schedule of Gardasil®. The secondary objectives include comparison in the immune response between WLWH receiving 2-dose schedule of SIIPL qHPV vaccine and a 3-dose schedule of SIIPL qHPV. The immunogenicity data will be collected up to Month 12 and data at 7-month will be considered for analysis of primary immunogenicity endpoints.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervavac administered as three doses | Experimental | Biological: Cervavac as three dose regimenRecombinant Quadrivalent Human Papillomavirus (Types 6,11 16, 18) Vaccine manufactured by Serum Institute of India Pvt Ltd administered as three doses at day 0, 60 and 180. |
| Cervavac administered as two doses | Experimental | Biological: Cervavac as two dose regimenRecombinant Quadrivalent Human Papillomavirus (Types 6,11 16, 18) Vaccine manufactured by Serum Institute of India Pvt Ltd administered as two doses at day 0 and 180. |
| Gardasil administered as three doses | Active comparator | Biological: Gardasil as three dose regimenRecombinant Quadrivalent Human Papillomavirus (Types 6,11 16, 18) Vaccine manufactured by MSD administered as three doses at day 0, 60 and 180. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Women Living with HIV aged 15-25 years at the time of screening
- Subjects with age 18 years and above, should be willing and able to provide written informed consent while for subjects <18*years of age, parents willing to provide written informed consent and subject is willing to sign written assent form for participation prior to initiating any study related procedure.
- Subject or parent willing to comply with all study requirements.
- Subjects who are determined by medical history, physical examination and clinical judgment of the Investigator to be eligible for inclusion in the study.
- Women of childbearing potential (WOCBP) (sexually active/ ≥18 years of age) must meet all the following criteria:
Key exclusion criteria (15 listed)
- Known history of prior vaccination with HPV vaccine.
- Concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens.
- Current diagnosis or prior history of genital warts or treatment of genital warts.
- Current diagnosis or history of treatment for cervical pre malignancies or malignancies.
- Pregnant females.
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 |
|---|---|---|
| Cervavac as three dose regimenCervavac manufactured by Serum Institute of India Pvt Ltd administered as three doses at day 0, 60 and 180. | Biological | Cervavac administered as three doses |
| Cervavac as two dose regimenCervavac manufactured by Serum Institute of India Pvt Ltd administered as two doses at day 0 and 180. | Biological | Cervavac administered as two doses |
| Gardasil as three dose regimenGardasil manufactured by MSD administered as a three doses at day 0,60 and 180. | Biological | Gardasil administered as three doses |
Primary outcome
Geometric mean titers of anti HPV 16 and 18 IgG antibodies
Time frame: at 1 month after the last dose
GMTs of anti HPV 16 and 18 IgG antibodies in WLWH receiving 3 doses of SIIPL qHPV and 3 doses of Gardasil®
3 secondary outcomes
Immune response (Geometric mean titers) of anti HPV 6 and 11 IgG antibodies
Time frame: at 1 month after the last dose
Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion
Time frame: at 1 month after the last dose
Adverse Events
Time frame: solicited AEs up to 7 days following each vaccination, unsolicited AEs from Day 0 through Month 7 and Month12 and SAEs from Day 0 through Month 7 and Month 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. Summary results for primary and secondary objectives
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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.
Carla Chibwesha principal investigator
Clinical HIV Research Unit, Helen Joseph Hospital, Johannesburg, South Africa
Nelly Mugo principal investigator
CCR, KEMRI, Nairobi-Kenya & PHRD, Thika-Kenya
Tacilta Nhampossa principal investigator
Manhiça Health Research Center - Manhiça Foundation,Manhiça
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cervavac as three dose regimen, Cervavac as two dose regimen and Gardasil as three dose regimen in people with Human Papillomavirus Infection, run by Serum Institute of India Pvt. Ltd. at 4 sites in 3 countries.
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 11 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Kenya, Mozambique, South Africa. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Geometric mean titers of anti HPV 16 and 18 IgG antibodies (time frame: at 1 month after the last dose). 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 29 Jun 2026.