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Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV Vaccine (A001)

Primary Purpose

HIV Infection

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

tgAAC09

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring HIV vaccine, Adeno-associated virus vactored vaccine, HIV-1 subtype C, Safety, Immunogenicity, Biodistribution, HIV prevention

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

SGS Biopharma
St. Pierre University Hospital
Univeristy of Bonn
University of Hamburg
National AIDS Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1 AAV-2 HIV Vaccine

Arm Description

64 volunteers receiving AAV-2 HIV vaccine tgAAC09 at 3 dosage levels, dose escalation and dose optimization

16 volunteers receiving formulation buffer consisting of a buffered salt solution with potassium phosphate, calcium chloride, magnesium chloride, and HEPES

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immunogenicity

Full Information

NCT ID

NCT00482027

First Posted

May 31, 2007

Last Updated

January 14, 2013

Sponsor

International AIDS Vaccine Initiative

Collaborators

Targeted Genetics Corporation, Children's Hospital of Philadelphia, Nationwide Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00482027

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Completed

Study Start Date

December 2003 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

International AIDS Vaccine Initiative

Collaborators

Targeted Genetics Corporation, Children's Hospital of Philadelphia, Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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)

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

HIV vaccine, Adeno-associated virus vactored vaccine, HIV-1 subtype C, Safety, Immunogenicity, Biodistribution, HIV prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 AAV-2 HIV Vaccine

Arm Type

Active Comparator

Arm Description

64 volunteers receiving AAV-2 HIV vaccine tgAAC09 at 3 dosage levels, dose escalation and dose optimization

Arm Title

Arm Type

Placebo Comparator

Arm Description

16 volunteers receiving formulation buffer consisting of a buffered salt solution with potassium phosphate, calcium chloride, magnesium chloride, and HEPES

Intervention Type

Biological

Intervention Name(s)

tgAAC09

Other Intervention Name(s)

AAV-2 HIV Vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety of one or two doses of tgAAC09

Description

Safety of one or two doses of tgAAC09 at 3 dosage levels in a dose-escalating an ddose-optimization study

Time Frame

One year

Secondary Outcome Measure Information:

Title

Immunogenicity

Time Frame

up to 6 months post 2nd injection

Other Pre-specified Outcome Measures:

Title

Biodistribution

Time Frame

upt to 6 montsh post 1st injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanjay Mehendale, MD

Organizational Affiliation

National AIDS Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nathan Clumeck, MD

Organizational Affiliation

St. Pierre University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jan van Lunzen, MD

Organizational Affiliation

University of Hamburg-Eppendorf

Official's Role

Principal Investigator

Facility Information:

Facility Name

SGS Biopharma

City

Antwerpen

ZIP/Postal Code

B-2060

Country

Belgium

Facility Name

St. Pierre University Hospital

City

Brussels

ZIP/Postal Code

B-1000

Country

Belgium

Facility Name

Univeristy of Bonn

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

University of Hamburg

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

National AIDS Research Institute

City

Pune

ZIP/Postal Code

411 026

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

18544020

Citation

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, Heald AE. A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C adeno-associated virus vaccine. AIDS Res Hum Retroviruses. 2008 Jun;24(6):873-80. doi: 10.1089/aid.2007.0292.

Results Reference

result

PubMed Identifier

20666584

Citation

Vardas E, Kaleebu P, Bekker LG, Hoosen A, Chomba E, Johnson PR, Anklesaria P, Birungi J, Barin B, Boaz M, Cox J, Lehrman J, Stevens G, Gilmour J, Tarragona T, Hayes P, Lowenbein S, Kizito E, Fast P, Heald AE, Schmidt C. A phase 2 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 vaccine based on adeno-associated virus. AIDS Res Hum Retroviruses. 2010 Aug;26(8):933-42. doi: 10.1089/aid.2009.0242.

Results Reference

derived

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

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