HIV InfectionPhase 1C001NCT00249106
Safety and Immunogenicity of a Plasmid HIV Vaccine in HIV Uninfected Adults
A Phase 1 study testing ADVAX in people with HIV Infection, run by International AIDS Vaccine Initiative at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety and immune response to a investigational DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels, in adults who are not infected with HIV. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- ADVAX
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2003to Oct 2005
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult males and females;
- Age at least 18 years on the day of screening and no greater than 60 years on the day of the first vaccination;
- Available for follow up for the planned duration of the study (screening plus 18 months);
- In the opinion of the principal investigator or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed;
- Willing to undergo HIV testing and counseling, and receive HIV test results;
- If sexually active female, using an effective method of contraception from screening until at least 4 months after last vaccination, and willing to undergo urine pregnancy test.
- If sexually active male, willing to use an effective method of contraception from screening until 4 months after the last vaccination.
Who cannot join
- Clinically relevant abnormality on history or examination including history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the designated trial physician in last 6 months;
- Any acute or chronic medical condition requiring care of a physician (e.g.,, diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation;
- Any of the following abnormal laboratory parameters that are moderate, severe, or very severe: haematology (hemoglobin, absolute neutrophil count, absolute lymphocyte count, absolute CD4/CD8 count, platelets); urinalysis, biochemistries (total bilirubin, creatinine, AST, ALT). Volunteers with mild laboratory abnormalities that are judged by the principal investigator or designee to be not clinically significant may be enrolled.
- Reported high- risk behaviour for HIV infection, defined as:
- Had unprotected vaginal or anal sex with a known HIV infected person or a casual partner (i.e., no continuing established relationship) within 6 months before vaccination
- Engaged in sex work for money or drugs within 6 months before vaccination
Show all 17Show fewer
- Used injection drugs (illicit), or Acquired an STD within 6 months before vaccination ;
- If female, pregnant or planning a pregnancy within 4 months after last vaccination or lactating;
- Receipt of blood transfusion or blood products 6 months prior to vaccination;
- Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of vaccination;
- Participation in another clinical trial of an investigational product currently or within past 12 weeks or expected participation during this study;
- Receipt of another experimental HIV vaccine at any time;
- Infected with HIV-1 or HIV-2 as indicated by ELISA and/or RT-PCR;
- History of severe local or systemic reaction to vaccination or history of severe allergic reactions;
- Confirmed diagnosis of hepatitis B (surface antigen, HbsAg); hepatitis C (HCV antibodies) or active syphillis;
- History of grand-mal epilepsy, or currently taking anti-epileptics;
- In the opinion of the investigator, unlikely to comply with protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rockefeller University Hospital
New York, New York, 10021
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Randomized, Placebo-Controlled, Dose-Escalating, Double-Blinded Phase 1 Safety and Immunogenicity Study of Clade C DNA Vaccine ADVAX e/g + ADVAX p/N-t (ADVAX) Administered Intramuscularly to HIV-Uninfected, Healthy Volunteers.
The purpose of this study is to determine the safety and immune response to a investigational DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels, in adults who are not infected with HIV.
Read the detailed description
This is a dose escalation trial. Study site staff and volunteers will be blinded, blinding will not apply to the assignment of dose levels (low, middle or high).
Volunteers will be screened up to 42 days before vaccination and will be followed for 18 months after the first vaccination.
15 volunteers will be randomized in a 4:1 ratio of active vaccine to placebo. Safety and tolerability of the ADVAX e/g + ADVAX p/n-t investigational product will be evaluated at least 14 days after the tenth volunteer in the lower dosage group receives the second injection before proceeding to the nextdosage group.
- Conditions
- HIV Infection
- Being tested
- ADVAX
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADVAXBiological
Also called DNA HIV vaccine
| Study group | Role | What they receive |
|---|---|---|
| HIV vaccine | Experimental | dosage escalation of ADVAX Receives: Biological: ADVAX |
| Placebo | Placebo comparator | Sodium phosphate Receives: Biological: ADVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ADVAX
dose escalation study
Measured: 18 months
Secondary outcomes (1)
Immunogenicity of ADVAX
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startDec 2003
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- International AIDS Vaccine Initiative
- Sponsor type
- Research network
- Collaborators
- Aaron Diamond AIDS Research Center, University of Rochester
- Responsible party
- Sponsor
- Investigators
- David Ho, MD, Principal investigator, Aaron Diamond AIDS Research CenterMichael Keefer, MD, Principal investigator, University of RochesterSoe Than, MD, Study director, International AIDS Vaccine Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249106
- Sponsor's protocol ID
- IAVI C001
- Acronym
- C001
- Status last verified
- Sep 2011
- First submitted
- 3 Nov 2005
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vasan S, Schlesinger SJ, Huang Y, Hurley A, Lombardo A, Chen Z, Than S, Adesanya P, Bunce C, Boaz M, Boyle R, Sayeed E, Clark L, Dugin D, Schmidt C, Song Y, Seamons L, Dally L, Ho M, Smith C, Markowitz M, Cox J, Gill DK, Gilmour J, Keefer MC, Fast P, Ho DD. Phase 1 safety and immunogenicity evaluation of ADVAX, a multigenic, DNA-based clade C/B' HIV-1 candidate vaccine. PLoS One. 2010 Jan 25;5(1):e8617. doi: 10.1371/journal.pone.0008617.
PubMed 20111582
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Dose-Escalating, Double-Blinded Phase 1 Safety and Immunogenicity Study of Clade C DNA Vaccine ADVAX e/g + ADVAX p/N-t (ADVAX) Administered Intramuscularly to HIV-Uninfected, Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00249106
- Acronym / sponsor ID
- C001 / IAVI C001
- Conditions
- HIV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- International AIDS Vaccine InitiativeResearch network
- Collaborators
- Aaron Diamond AIDS Research Center, University of Rochester
- Study start
- Dec 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 7 Nov 2005 (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 the safety and immune response to a investigational DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels, in adults who are not infected with HIV.
Detailed description
This is a dose escalation trial. Study site staff and volunteers will be blinded, blinding will not apply to the assignment of dose levels (low, middle or high).
Volunteers will be screened up to 42 days before vaccination and will be followed for 18 months after the first vaccination.
15 volunteers will be randomized in a 4:1 ratio of active vaccine to placebo. Safety and tolerability of the ADVAX e/g + ADVAX p/n-t investigational product will be evaluated at least 14 days after the tenth volunteer in the lower dosage group receives the second injection before proceeding to the nextdosage group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV vaccine | Experimental | Biological: ADVAXdosage escalation of ADVAX |
| Placebo | Placebo comparator | Biological: ADVAXSodium phosphate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy, adult males and females;
- Age at least 18 years on the day of screening and no greater than 60 years on the day of the first vaccination;
- Available for follow up for the planned duration of the study (screening plus 18 months);
- In the opinion of the principal investigator or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed;
- Willing to undergo HIV testing and counseling, and receive HIV test results;
Key exclusion criteria (17 listed)
- Clinically relevant abnormality on history or examination including history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the designated trial physician in last 6 months;
- Any acute or chronic medical condition requiring care of a physician (e.g.,, diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation;
- Any of the following abnormal laboratory parameters that are moderate, severe, or very severe: haematology (hemoglobin, absolute neutrophil count, absolute lymphocyte count, absolute CD4/CD8 count, platelets); urinalysis, biochemistries (total bilirubin, creatinine, AST, ALT). Volunteers with mild laboratory abnormalities that are judged by the principal investigator or designee to be not clinically significant may be enrolled.
- Reported high- risk behaviour for HIV infection, defined as:
- Had unprotected vaginal or anal sex with a known HIV infected person or a casual partner (i.e., no continuing established relationship) within 6 months before 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 |
|---|---|---|
| ADVAXAlso: DNA HIV vaccine | Biological | HIV vaccine, Placebo |
Primary outcome
Safety of ADVAX
Time frame: 18 months
dose escalation study
1 secondary outcome
Immunogenicity of ADVAX
Time frame: 18 months
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 11 Feb 2013.
- Results publication: PubMed 20111582Vasan S, Schlesinger SJ, Huang Y, Hurley A, Lombardo A, Chen Z, Than S, Adesanya P, Bunce C, Boaz M, Boyle R, Sayeed E, Clark L, Dugin D, Schmidt C, Song Y, Seamons L, Dally L, Ho M, Smith C, Markowitz M, Cox J, Gill DK, Gilmour J, Keefer MC, Fast P, Ho DD. Phase 1 safety and immunogenicity evaluation of ADVAX, a multigenic, DNA-based clade C/B' HIV-1 candidate vaccine. PLoS One. 2010 Jan 25;5(1):e8617. doi: 10.1371/journal.pone.0008617.
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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.
David Ho, MD principal investigator
Aaron Diamond AIDS Research Center
Michael Keefer, MD principal investigator
University of Rochester
Soe Than, MD study director
International AIDS Vaccine Initiative
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADVAX in people with HIV Infection, run by International AIDS Vaccine Initiative at 2 sites in United States.
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 7 inclusion and 17 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 ADVAX (time frame: 18 months). 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 NCT00249106, which also lists 1 linked publication.
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 11 Feb 2013.