Safety and Immunogenicity Study of SeV-G(NP) HIV Vaccine Administered Intranasally and Ad35-GRIN HIV Vaccine Given Intramuscularly in Prime-Boost Regimens in HIV-Uninfected Volunteers

HIV Infections Clinical Trial

Official title:

A Phase I Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety and Immunogenicity of a Sendai HIV Vaccine SeV-G(NP) Given Intranasally and Ad35-GRIN Administered Intramuscularly in Prime-Boost Regimens in HIV-Uninfected, Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705990
• Other study ID #: IAVI S001
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2012
• Last updated: August 25, 2015
• Start date: March 2013

Study information

• Verified date: August 2015
• Source: International AIDS Vaccine Initiative
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRwanda: Ethics CommitteeRwanda: Ministry of HealthKenya: Kenyatta National Hospital/University of Nairobi Ethics and Research CommitteeKenya: Ministry of HealthKenya: Pharmacy and Poisons BoardUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers.

Description:

The study is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing the safety, tolerability, and immunogenicity of SeV-G(NP) given intranasally by drops and Ad35-GRIN administered intramuscularly in each of four prime-boost regimens.

Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the last vaccine administration (16 months after the first vaccination). It is anticipated that it will take approximately 6 months to enroll the study. Approximately 64 volunteers (48 vaccine and 16 placebo recipients) will be included in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy male or female adults,

• 18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda),

• who do not report high-risk behaviour for HIV infection,

• who are available for the duration of the trial,

• who are willing to undergo HIV testing,

• use an effective method of contraception, and

• who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent.

Exclusion Criteria:

• confirmed HIV infection,

• pregnancy and lactation,

• significant acute or chronic disease,

• clinically significant laboratory abnormalities,

• recent vaccination or receipt of a blood product,

• previous receipt of an HIV vaccine, and

• previous severe local or systemic reactions to vaccination or history of severe allergic reactions.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• SeV-G(NP) (0.2mL, 2x10^7 CIU)
Delivered intranasally by drops
• SeV-G(NP) (0.2mL, 2x10^8 CIU)
Delivered intranasally by drops
• Ad35-GRIN (0.5mL)
(1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection

Locations

Country	Name	City	State
Kenya	Kenya AIDS Vaccine Initiative	Nairobi
Rwanda	Project San Francisco	Kigali
United Kingdom	St. Stephen's Centre	London

Sponsors (1)

Lead Sponsor	Collaborator
International AIDS Vaccine Initiative

Countries where clinical trial is conducted

Kenya,  Rwanda,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability	To evaluate the safety and tolerability of SeV-G(NP) and Ad35-GRIN administered in four prime-boost regimens.	16 months approximately	Yes
Secondary	Shedding	To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert	16 months	No
Secondary	Immunogenicity	To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.	16 months	No

External Links

•   International AIDS Vaccine Initiative