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)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Dec 2003

Typical duration for phase_1

Geographic Reach

3 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

Study Start

First participant enrolled

December 1, 2003

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2007

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed

Last Updated

January 16, 2013

Status Verified

May 1, 2007

Enrollment Period

3 years

First QC Date

May 31, 2007

Last Update Submit

January 14, 2013

Conditions

HIV Infection

Keywords

HIV vaccineAdeno-associated virus vactored vaccineHIV-1 subtype CSafetyImmunogenicityBiodistributionHIV prevention

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Immunogenicity
up to 6 months post 2nd injection

Other Outcomes (1)

Biodistribution
upt to 6 montsh post 1st injection

Study Arms (2)

1 AAV-2 HIV Vaccine

ACTIVE COMPARATOR

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

Biological: tgAAC09

2

PLACEBO COMPARATOR

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

Interventions

tgAAC09BIOLOGICAL

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

Also known as: AAV-2 HIV Vaccine

1 AAV-2 HIV Vaccine

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

International AIDS Vaccine Initiativelead
Targeted Genetics Corporationcollaborator
Children's Hospital of Philadelphiacollaborator
Nationwide Children's Hospitalcollaborator

Study Sites (5)

SGS Biopharma

Antwerp, B-2060, Belgium

Location

St. Pierre University Hospital

Brussels, B-1000, Belgium

Location

Univeristy of Bonn

Bonn, 53127, Germany

Location

University of Hamburg

Hamburg, 20246, Germany

Location

National AIDS Research Institute

Pune, 411 026, India

Location

Related Publications (2)

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.
PMID: 18544020RESULT
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.
PMID: 20666584DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

Sanjay Mehendale, MD
National AIDS Research Institute
PRINCIPAL INVESTIGATOR
Nathan Clumeck, MD
St. Pierre University Hospital
PRINCIPAL INVESTIGATOR
Jan van Lunzen, MD
University of Hamburg-Eppendorf
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: FACTORIAL
Sponsor Type: NETWORK
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 31, 2007

First Posted

June 4, 2007

Study Start

December 1, 2003

Primary Completion

December 1, 2006

Study Completion

January 1, 2007

Last Updated

January 16, 2013

Record last verified: 2007-05

Locations

IN(1)DE(2)BE(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

1 AAV-2 HIV Vaccine

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations