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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier:
NCT01705990
First received: October 10, 2012
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: SeV-G(NP) (0.2mL, 2x10^7 CIU)
Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)
Biological: Ad35-GRIN (0.5mL)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by International AIDS Vaccine Initiative:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 16 months approximately ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of SeV-G(NP) and Ad35-GRIN administered in four prime-boost regimens.


Secondary Outcome Measures:
  • Shedding [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert

  • Immunogenicity [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.


Estimated Enrollment: 64
Study Start Date: March 2013
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: SeV-G(NP) followed by Ad35-GRIN
SeV-G(NP) (IN) at 2x10^7 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4)
Biological: SeV-G(NP) (0.2mL, 2x10^7 CIU)
Delivered intranasally by drops
Biological: Ad35-GRIN (0.5mL)
(1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection
Experimental: Group B: SeV-G(NP) followed by Ad35-GRIN
SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4)
Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)
Delivered intranasally by drops
Biological: Ad35-GRIN (0.5mL)
(1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection
Experimental: Group C: Ad35-GRIN followed by SeV-G(NP)
Ad35-GRIN (IM) at 1x10^10 vp at Month 0 followed by SeV-G(NP) (IN) at 2x10^8 CIU at Month 4. (Vaccine/Placebo = 12/4)
Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)
Delivered intranasally by drops
Biological: Ad35-GRIN (0.5mL)
(1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection
Experimental: Group D: SeV-G(NP) only
SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 and 4. (Vaccine/Placebo = 12/4)
Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)
Delivered intranasally by drops

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705990

Locations
Kenya
Kenya AIDS Vaccine Initiative
Nairobi, Kenya
Rwanda
Project San Francisco
Kigali, Rwanda
United Kingdom
St. Stephen's Centre
London, United Kingdom
Sponsors and Collaborators
International AIDS Vaccine Initiative
  More Information

Additional Information:
No publications provided

Responsible Party: International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier: NCT01705990     History of Changes
Other Study ID Numbers: IAVI S001
Study First Received: October 10, 2012
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration
Rwanda: Ethics Committee
Rwanda: Ministry of Health
Kenya: Kenyatta National Hospital/University of Nairobi Ethics and Research Committee
Kenya: Ministry of Health
Kenya: Pharmacy and Poisons Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by International AIDS Vaccine Initiative:
HIV
AIDS
HIV vaccine
HIV prevention

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 29, 2014