HIV InfectionPhase 1A001NCT00482027
Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV Vaccine
A Phase 1 study testing tgAAC09 in people with HIV Infection, run by International AIDS Vaccine Initiative at 5 sites in 3 countries.
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) Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- tgAAC09
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Dec 2003to Jan 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Belgium2 sites
SGS Biopharma
Antwerp, B-2060
St. Pierre University Hospital
Brussels, B-1000
Germany2 sites
Univeristy of Bonn
Bonn, 53127
University of Hamburg
Hamburg, 20246
About this study
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
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)
Read the 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.
- Conditions
- HIV Infection
- Being tested
- tgAAC09
- Keywords
- HIV vaccine, Adeno-associated virus vactored vaccine, HIV-1 subtype C, Safety, Immunogenicity, Biodistribution, HIV prevention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tgAAC09Biological
Also called AAV-2 HIV Vaccine
one or 2 doses of AAV-2 HIV vaccine (tgAAC09) at 3 dosage levels, dose escalation and dose optimization
| Study group | Role | What they receive |
|---|---|---|
| 1 AAV-2 HIV Vaccine | Active comparator | 64 volunteers receiving AAV-2 HIV vaccine tgAAC09 at 3 dosage levels, dose escalation and dose optimization Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (1)
Immunogenicity
Measured: up to 6 months post 2nd injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startDec 2003
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- International AIDS Vaccine Initiative
- Sponsor type
- Research network
- Collaborators
- Targeted Genetics Corporation, Children's Hospital of Philadelphia, Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Sanjay Mehendale, MD, Principal investigator, National AIDS Research InstituteNathan Clumeck, MD, Principal investigator, St. Pierre University HospitalJan van Lunzen, MD, Principal investigator, University of Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482027
- Sponsor's protocol ID
- A001
- Acronym
- A001
- Status last verified
- May 2007
- First submitted
- 31 May 2007
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18544020Vardas 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.
PubMed 20666584
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00482027
- Acronym / sponsor ID
- A001 / A001
- Conditions
- HIV Infection
- Keywords
- HIV vaccine, Adeno-associated virus vactored vaccine, HIV-1 subtype C, Safety, Immunogenicity, Biodistribution, HIV prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- International AIDS Vaccine InitiativeResearch network
- Collaborators
- Targeted Genetics Corporation, Children's Hospital of Philadelphia, Nationwide Children's Hospital
- Study start
- Dec 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 4 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 AAV-2 HIV Vaccine | Active comparator | Biological: tgAAC0964 volunteers receiving AAV-2 HIV vaccine tgAAC09 at 3 dosage levels, dose escalation and dose optimization |
| 2 | Placebo comparator | –16 volunteers receiving formulation buffer consisting of a buffered salt solution with potassium phosphate, calcium chloride, magnesium chloride, and HEPES |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tgAAC09Also: AAV-2 HIV Vaccineone or 2 doses of AAV-2 HIV vaccine (tgAAC09) at 3 dosage levels, dose escalation and dose optimization | Biological | 1 AAV-2 HIV Vaccine |
Primary outcome
Safety of one or two doses of tgAAC09
Time frame: One year
Safety of one or two doses of tgAAC09 at 3 dosage levels in a dose-escalating an ddose-optimization study
1 secondary outcome
Immunogenicity
Time frame: up to 6 months post 2nd injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Results publication: PubMed 18544020Mehendale 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.
- Derived from this study: PubMed 20666584Vardas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Mehendale, MD principal investigator
National AIDS Research Institute
Nathan Clumeck, MD principal investigator
St. Pierre University Hospital
Jan van Lunzen, MD principal investigator
University of Hamburg-Eppendorf
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tgAAC09 in people with HIV Infection, run by International AIDS Vaccine Initiative at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Germany, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of one or two doses of tgAAC09 (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00482027, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.