Trial record 5 of 37 for:
" September 19, 2012":" October 19, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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 currently recruiting participants.
Verified April 2013 by International AIDS Vaccine Initiative
Sponsor:
International AIDS Vaccine Initiative
Information provided by (Responsible Party):
International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier:
NCT01705990
First received: October 10, 2012
Last updated: April 3, 2013
Last verified: April 2013
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01705990
Locations
| Kenya | |
| Kenya AIDS Vaccine Initiative | Not yet recruiting |
| Nairobi, Kenya | |
| Contact: Omu Anzala, MBChB, PhD +254 202 714 613 oanzala@kaviuon.org | |
| Principal Investigator: Omu Anzala, MBChB, PhD | |
| Rwanda | |
| Project San Francisco | Recruiting |
| Kigali, Rwanda | |
| Contact: Etienne Karita, MD, M.Sc., MSPH +1 250 503 233 ekarita@rzhrg-mail.org | |
| Principal Investigator: Etienne Karita, MD, M.Sc., MSPH | |
| United Kingdom | |
| St. Stephen's Centre | Not yet recruiting |
| London, United Kingdom | |
| Contact: Brian Gazzard, MD + 44 208 746 8239 brian.gazzard@chelwest.nhs.uk | |
| Principal Investigator: Brian Gazzard, MD | |
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: | April 3, 2013 |
| 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 June 17, 2013