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Trial record 7 of 32 for:    IAVI

A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04794218
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : November 23, 2021
Sponsor:
Collaborators:
George Washington University
Brigham and Women's Hospital
Redemption Hospital
East-West Medical Research Institute
Information provided by (Responsible Party):
International AIDS Vaccine Initiative

Brief 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

Condition or disease Intervention/treatment Phase
Lassa Fever Lassa Virus Infection Drug: rVSV∆G-LASV-GPC Other: Placebo/Diluent Phase 1

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 105 participants (84 active product and 21 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : June 23, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety Vaccines

Arm Intervention/treatment
Experimental: Study Group 1
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^4 or Placebo
Drug: rVSV∆G-LASV-GPC
2 × 10^4 pfu delivered intramuscularly

Other: Placebo/Diluent
N/A delivered intramuscularly

Experimental: Study Group 2
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo
Drug: rVSV∆G-LASV-GPC
2 × 10^5 pfu delivered intramuscularly

Other: Placebo/Diluent
N/A delivered intramuscularly

Experimental: Study Group 3
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo
Drug: rVSV∆G-LASV-GPC
2 × 10^6 pfu delivered intramuscularly

Other: Placebo/Diluent
N/A delivered intramuscularly

Experimental: Study Group 4
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo
Drug: rVSV∆G-LASV-GPC
2 × 10^7 pfu delivered intramuscularly

Other: Placebo/Diluent
N/A delivered intramuscularly

Experimental: Study Group 5
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo
Drug: rVSV∆G-LASV-GPC
2 × 10^5 pfu delivered intramuscularly

Other: Placebo/Diluent
N/A delivered intramuscularly

Experimental: Study Group 6
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo
Drug: rVSV∆G-LASV-GPC
2 × 10^6 pfu delivered intramuscularly

Other: Placebo/Diluent
N/A delivered intramuscularly

Experimental: Study Group 7
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo
Drug: rVSV∆G-LASV-GPC
2 × 10^7 pfu delivered intramuscularly

Other: Placebo/Diluent
N/A delivered intramuscularly




Primary Outcome Measures :
  1. Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine [ Time Frame: 9 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


Secondary Outcome Measures :
  1. Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine [ Time Frame: 17 months ]
    • 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Adults in good general health as assessed by medical history, physical examination, and laboratory tests
  2. At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of vaccination
  3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
  4. Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results
  5. Use effective method of contraception
  6. Understand the study and provide written informed consent

Exclusion Criteria

  1. Confirmed HIV-1 or HIV-2 infection
  2. Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease
  3. Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study
  4. Pregnant or lactating
  5. Bleeding disorder that was diagnosed by a physician
  6. Prior receipt of another investigational Lassa vaccine candidate
  7. Receipt of blood transfusion or blood-derived products within the previous 3 months
  8. Prior exposure to LASV as documented by history
  9. History of severe local or systemic reactogenicity to any vaccine
  10. Body mass index (BMI) ≥35
  11. Mild or greater hearing impairment defined as ≥26dB loss in either ear

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04794218


Contacts
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Contact: Dagna Laufer +1-212-328-7459 dlaufer@iavi.org

Locations
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United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Elissa Malkin    202-994-1994    emalkin@email.gwu.edu   
United States, Hawaii
East-West Medical Research Institute Recruiting
Honolulu, Hawaii, United States, 96814
Contact: David Fitz-Patrick, MD    808-440-4426    dfitz@eastwestresearch.com   
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Brookline, Massachusetts, United States, 02115
Contact: Lindsey Baden    617-732-8881    LBADEN@BWH.HARVARD.EDU   
Liberia
Redemption Hospital Not yet recruiting
New Kru Town, Greater Monrovia, Liberia
Contact: Mark Kieh    +231-770-332-591    MKieh@prevailcr.org   
Sponsors and Collaborators
International AIDS Vaccine Initiative
George Washington University
Brigham and Women's Hospital
Redemption Hospital
East-West Medical Research Institute
Additional Information:
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Responsible Party: International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier: NCT04794218    
Other Study ID Numbers: IAVI C102
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lassa Fever
Virus Diseases
Infections
Arenaviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral