Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV Vaccine

HIV Infection Clinical Trial

— A001  

Official title:

A Phase 1 Randomized, Placebo-controlled, Double-blind Dose-escalation Trial to Evaluate the Safety and Immunogenicity of tgAAC09, a Gag-PR-RT AAV HIV Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482027
• Other study ID #: A001
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2007
• Last updated: January 14, 2013
• Start date: December 2003
• Est. completion date: January 2007

Study information

• Verified date: May 2007
• Source: International AIDS Vaccine Initiative
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical ResearchIndia: Institutional Review BoardIndia: Ministry of HealthBelgium: Institutional Review BoardGermany: Ethics CommissionGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine safety and immunogenicity (ability to induce an immune response) of a novel HIV vaccine based on adeno-associated virus (AAV)

Description:

The need for a vaccine to prevent AIDS and interrupt transmission of HIV is indisputable. To be effective, an HIV vaccine will have to induce cellular and humoral immune responses that are durable and potent. Intra-muscular delivery of HIV genes enclosed within recombinant adeno-associated virus (rAAV) protein capsid has been shown to be a potent inducer of both antibodies and T-cell responses in animal studies. tgAAC09, consisting of single-stranded DNA from Clade C HIV-1 genes for the gag, protease and part of the reverse transcriptase proteins enclosed within a rAAV serotype 2 protein capsid, was developed as one component of a multi-component HIV vaccine. The purpose of this study is to evaluate the safety and immunogenicity of tgAAC09 in healthy, HIV-seronegative volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy males and females

• Age at least 18 years on the day of screening and no greater than 50 years on the day of vaccination

• Available for follow-up for the planned duration of the study (screening plus 12 months)

• Able to give written informed consent;

• No reported high-risk behavior for HIV (Appendix C), willing to undergo HIV testing and receive results;

• If sexually active, willing to use or have partner use condoms from screening until at least 4 months after the vaccination. Additional means of contraception are permitted and encouraged.

Exclusion Criteria:

• Clinically relevant abnormality on history or examination including history of immunodeficiency or use of immunosuppressive medication in last 6 months;

• A chronic medical condition or concurrent condition, which, in the opinion of the investigator, would make the volunteer unsuitable for the study.

• Any of the following abnormal laboratory parameters that are mild and judged to be clinically significant by the principal investigator or designee, or moderate, severe, or very severe: hematology (hemoglobin, absolute neutrophil count [ANC] absolute lymphocyte count [ALC], absolute CD4 count, platelets); urinalysis, clinical chemistry (total bilirubin, creatinine, AST, ALT). Refer to Appendix D for the grading of these laboratory parameters.

• If female, pregnant or planning a pregnancy within 4 months after receiving the vaccine, or lactating;

• Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of vaccination;

• Receipt of other experimental HIV vaccine at any time;

• Receipt of blood transfusion or blood products within 6 months of vaccination;

• Participation in another clinical trial of an investigational product currently or within 12 weeks of vaccination, or expected during participation in this study;

• History of severe local or systemic reaction to vaccination or history of allergic reactions to vaccines;

• Confirmed infection with HIV-1 or HIV-2;

• Positive for hepatitis B (surface antigen), hepatitis C antibodies, or active syphilis (confirmed by treponemal test such as TPHA in addition to non-treponemal test such as RPR) or active tuberculosis.

• Unlikely to comply with protocol.

Study Design

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

Related Conditions & MeSH terms

• HIV Infection

Intervention

Biological:
• tgAAC09
one or 2 doses of AAV-2 HIV vaccine (tgAAC09) at 3 dosage levels, dose escalation and dose optimization

Locations

Country	Name	City	State
Belgium	SGS Biopharma	Antwerpen
Belgium	St. Pierre University Hospital	Brussels
Germany	Univeristy of Bonn	Bonn
Germany	University of Hamburg	Hamburg
India	National AIDS Research Institute	Pune

Sponsors (4)

Lead Sponsor	Collaborator
International AIDS Vaccine Initiative	Children's Hospital of Philadelphia, Nationwide Children's Hospital, Targeted Genetics Corporation

Countries where clinical trial is conducted

Belgium,  Germany,  India, 

References & Publications (1)

Mehendale S, van Lunzen J, Clumeck N, Rockstroh J, Vets E, Johnson PR, Anklesaria P, Barin B, Boaz M, Kochhar S, Lehrman J, Schmidt C, Peeters M, Schwarze-Zander C, Kabamba K, Glaunsinger T, Sahay S, Thakar M, Paranjape R, Gilmour J, Excler JL, Fast P, He — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biodistribution		upt to 6 montsh post 1st injection	Yes
Primary	Safety of one or two doses of tgAAC09	Safety of one or two doses of tgAAC09 at 3 dosage levels in a dose-escalating an ddose-optimization study	One year	Yes
Secondary	Immunogenicity		up to 6 months post 2nd injection	No