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

Lassa Fever Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04794218
• Other study ID #: IAVI C102
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 23, 2021
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: International AIDS Vaccine Initiative
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: March 2024
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 51 Years

Eligibility

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

Related Conditions & MeSH terms

• Lassa Fever
• Lassa Virus Infection

Intervention

Drug:
• rVSV?G-LASV-GPC
2 × 10^4 pfu delivered intramuscularly
• rVSV?G-LASV-GPC
2 × 10^5 pfu delivered intramuscularly
• rVSV?G-LASV-GPC
2 × 10^6 pfu delivered intramuscularly
• rVSV?G-LASV-GPC
2 × 10^7 pfu delivered intramuscularly

Other:
• Placebo/Diluent
N/A delivered intramuscularly

Locations

Country	Name	City	State
Liberia	Redemption Hospital	New Kru Town	Greater Monrovia
United States	Brigham and Women's Hospital	Brookline	Massachusetts
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	George Washington University	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
International AIDS Vaccine Initiative	Brigham and Women's Hospital, East-West Medical Research Institute, George Washington University, Redemption Hospital

Countries where clinical trial is conducted

United States,  Liberia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	20 months
Secondary	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	20 months

External Links

•   Related Info