Lassa FeverPhase 1NCT04794218
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath
A Phase 1 study testing rVSV∆G-LASV-GPC in people with Lassa Fever and Lassa Virus Infection, run by International AIDS Vaccine Initiative at 4 sites in 2 countries.
Trial summary
A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health Read more about this study
- Who is it for?
- Ages 18 to 51 yearsHealthy volunteers can take part
- Conditions the study is for
- Lassa Fever, Lassa Virus Infection
- What is being tested?
- rVSV∆G-LASV-GPC
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Jun 2021to Mar 2024
- Phase
- Phase 1
- 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 18 to 51 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults in good general health as assessed by medical history, physical examination, and laboratory tests
- At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of vaccination
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
- Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results
- Use effective method of contraception
- Understand the study and provide written informed consent
Who cannot join
- Confirmed HIV-1 or HIV-2 infection
- Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease
- Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study
- Pregnant or lactating
- Bleeding disorder that was diagnosed by a physician
- Prior receipt of another investigational Lassa vaccine candidate
Show all 11Show fewer
- Receipt of blood transfusion or blood-derived products within the previous 3 months
- Prior exposure to LASV as documented by history
- History of severe local or systemic reactogenicity to any vaccine
- Body mass index (BMI) ≥35
- Mild or greater hearing impairment defined as ≥26dB loss in either ear
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Brigham and Women's Hospital
Brookline, Massachusetts, 02115
East-West Medical Research Institute
Honolulu, Hawaii, 96814
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath
A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health
Read the detailed description
This is a Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health.
Approximately 110 participants (88 active product and 22 placebo recipients) will be included in the study Participants will be screened up to 42 days before IP administration and will be followed for 12 months after IP administration.
- Conditions
- Lassa Fever, Lassa Virus Infection
- Being tested
- rVSV∆G-LASV-GPC, Placebo/Diluent
- Medical subject headings
- Lassa Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rVSV∆G-LASV-GPCDrug
2 × 10^4 pfu delivered intramuscularly
rVSV∆G-LASV-GPCDrug
2 × 10^5 pfu delivered intramuscularly
rVSV∆G-LASV-GPCDrug
2 × 10^6 pfu delivered intramuscularly
rVSV∆G-LASV-GPCDrug
2 × 10^7 pfu delivered intramuscularly
Placebo/DiluentOther
N/A delivered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^4 or Placebo Receives: Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent |
| Study Group 2 | Experimental | rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo Receives: Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent |
| Study Group 3 | Experimental | rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo Receives: Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent |
| Study Group 4A | Experimental | rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo Receives: Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent |
| Study Group 5 | Experimental | rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo Receives: Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent |
| Study Group 6 | Experimental | rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo Receives: Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent |
| Study Group 7 | Experimental | rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo Receives: Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent |
| Study Group 4B | Experimental | rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10^7 or Placebo Receives: Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine
- Proportion of participants with Grade 3 or higher reactogenicity (ie, solicited AEs) during a 14-day follow-up period after IP administration
- Proportion of participants with Grade 2 or higher IP-related unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration
- Proportion of participants with Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration
- Proportion of participants with IP-related SAEs throughout the study period Proportion of participants with AEs of Special Interest (AESI) post-vaccination throughout the study period
Measured: 20 months
Secondary outcomes (1)
Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine
- Magnitude and duration of viral RNA in plasma by PCR
- Magnitude and duration of rVSV∆G-LASV-GPC vaccine viremia by culture
- Magnitude and duration of viral RNA in urine and saliva by PCR
- Magnitude and duration of rVSV∆G-LASV-GPC vaccine shedding in urine and saliva by culture
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start23 Jun 2021
- Primary completion19 Dec 2023
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lassa FeverStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- International AIDS Vaccine Initiative
- Sponsor type
- Research network
- Collaborators
- George Washington University, Brigham and Women's Hospital, Redemption Hospital, East-West Medical Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794218
- Sponsor's protocol ID
- IAVI C102
- Status last verified
- Jan 2024
- First submitted
- 3 Mar 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Malkin E, Zaric M, Kieh M, Baden LR, Fitz-Patrick D, Marini A, Yun H, Hayes P, Bromell R, Ayorinde M, Fernandez N, Varma R, Sigei F, Ward M, Pindolia H, Sewell S, Amini F, Blie J, Wilson B, Faley P, McCullough J, Tokpah F, Wisseh C, Towalid E, Hadawale S, Sayeed E, Hunt D, Keshavarzi N, Barin B, Maljkovic Berry I, Parks CL, Truter SG, Walker K, Vekemans J, Lehrman J, Engelbrecht M, Malherbe M, Laufer D, Philiponis V, Higgs E, Mutua G, Fast PE, Gupta SB; rVSVDeltaG-LASV-GPC Study Group. Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate. N Engl J Med. 2025 Nov 6;393(18):1807-1818. doi: 10.1056/NEJMoa2501073.
PubMed 41191941
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath
- ClinicalTrials.gov ID
- NCT04794218
- Acronym / sponsor ID
- IAVI C102
- Conditions
- Lassa Fever, Lassa Virus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- International AIDS Vaccine InitiativeResearch network
- Collaborators
- George Washington University, Brigham and Women's Hospital, Redemption Hospital, East-West Medical Research Institute
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- Mar 2024 (estimated)
- First posted
- 11 Mar 2021 (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.
A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health
Detailed description
This is a Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health.
Approximately 110 participants (88 active product and 22 placebo recipients) will be included in the study Participants will be screened up to 42 days before IP administration and will be followed for 12 months after IP administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Drug: rVSV∆G-LASV-GPC, Other: Placebo/DiluentrVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^4 or Placebo |
| Study Group 2 | Experimental | Drug: rVSV∆G-LASV-GPC, Other: Placebo/DiluentrVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo |
| Study Group 3 | Experimental | Drug: rVSV∆G-LASV-GPC, Other: Placebo/DiluentrVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo |
| Study Group 4A | Experimental | Drug: rVSV∆G-LASV-GPC, Other: Placebo/DiluentrVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo |
| Study Group 5 | Experimental | Drug: rVSV∆G-LASV-GPC, Other: Placebo/DiluentrVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo |
| Study Group 6 | Experimental | Drug: rVSV∆G-LASV-GPC, Other: Placebo/DiluentrVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo |
| Study Group 7 | Experimental | Drug: rVSV∆G-LASV-GPC, Other: Placebo/DiluentrVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo |
| Study Group 4B | Experimental | Drug: rVSV∆G-LASV-GPC, Other: Placebo/DiluentrVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10^7 or Placebo |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults in good general health as assessed by medical history, physical examination, and laboratory tests
- At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of vaccination
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
- Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results
- Use effective method of contraception
Key exclusion criteria (11 listed)
- Confirmed HIV-1 or HIV-2 infection
- Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease
- Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study
- Pregnant or lactating
- Bleeding disorder that was diagnosed by a physician
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 |
|---|---|---|
| rVSV∆G-LASV-GPC2 × 10^4 pfu delivered intramuscularly | Drug | Study Group 1 |
| rVSV∆G-LASV-GPC2 × 10^5 pfu delivered intramuscularly | Drug | Study Group 2, Study Group 5 |
| rVSV∆G-LASV-GPC2 × 10^6 pfu delivered intramuscularly | Drug | Study Group 3, Study Group 6 |
| rVSV∆G-LASV-GPC2 × 10^7 pfu delivered intramuscularly | Drug | Study Group 4A, Study Group 4B, Study Group 7 |
| Placebo/DiluentN/A delivered intramuscularly | Other | Study Group 1, Study Group 2, Study Group 3, Study Group 4A, Study Group 4B, Study Group 5, Study Group 6, Study Group 7 |
Primary outcome
Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine
Time frame: 20 months
* Proportion of participants with Grade 3 or higher reactogenicity (ie, solicited AEs) during a 14-day follow-up period after IP administration * Proportion of participants with Grade 2 or higher IP-related unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration * Proportion of participants with Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration * Proportion of participants with IP-related SAEs throughout the study period Proportion of participants with AEs of Special Interest (AESI) post-vaccination throughout the study period
1 secondary outcome
Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine
Time frame: 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 41191941Malkin E, Zaric M, Kieh M, Baden LR, Fitz-Patrick D, Marini A, Yun H, Hayes P, Bromell R, Ayorinde M, Fernandez N, Varma R, Sigei F, Ward M, Pindolia H, Sewell S, Amini F, Blie J, Wilson B, Faley P, McCullough J, Tokpah F, Wisseh C, Towalid E, Hadawale S, Sayeed E, Hunt D, Keshavarzi N, Barin B, Maljkovic Berry I, Parks CL, Truter SG, Walker K, Vekemans J, Lehrman J, Engelbrecht M, Malherbe M, Laufer D, Philiponis V, Higgs E, Mutua G, Fast PE, Gupta SB; rVSVDeltaG-LASV-GPC Study Group. Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate. N Engl J Med. 2025 Nov 6;393(18):1807-1818. doi: 10.1056/NEJMoa2501073.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rVSV∆G-LASV-GPC in people with Lassa Fever and Lassa Virus Infection, run by International AIDS Vaccine Initiative at 4 sites in 2 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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 United States, Liberia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04794218, which also lists 1 linked publication.
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 18 Jan 2024.