HIV InfectionsPhase 1NCT01159990
Antigenic Competition in HIV Preventive Vaccines
A Phase 1 study testing rAd5 Gag-Pol Env A/B/C and rAd5 Gag-Pol in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 4 countries.
Trial summary
HIV vaccines are designed to create an immune response to certain components of the HIV virus called peptides. Previous research indicates that one peptide, called Gag, may be particularly important for stimulating an immune response to HIV. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- rAd5 Gag-Pol Env A/B/C and rAd5 Gag-Pol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jan 2011to 6 Apr 2017
- 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
- Access to a participating HIV Vaccine Trials Network (HVTN) Clinical Research Site (CRS) and willingness to be followed for the planned duration of the study
- Completes a questionnaire prior to vaccination that demonstrates an understanding of this study and that in a previous trial there was an association of increased HIV acquisition with receipt of that study vaccine
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks, amenable to HIV risk reduction counseling, and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
- Willingness to continue annual follow-up contact after the last required protocol clinic visit, for a total of 5 years following enrollment
- Good general health as shown by medical history, physical exam, and screening laboratory tests
Show all 20Show fewer
- Assessed by the clinic staff as being at low risk for HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment
- Adenovirus 5 (Ad5) neutralizing antibody (nAb) titer less than 1:18
- Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, or greater than or equal to 13.0 g/dL for volunteers who were born male
- White blood cell (WBC) count between 3,300 and 12,000 cells/mm3
- Total lymphocyte count greater than or equal to 800 cells/mm3
- Remaining differential either within institutional normal range or with site physician approval
- Platelet count between 125,000 and 550,000/mm3
- Alanine aminotransferase (ALT) less than or equal to 1.25 times institutional upper limits of normal
- Negative HIV-1 and HIV-2 blood test: U.S. participants must have negative FDA-approved enzyme immunoassay (EIA). Non-U.S. sites may use locally available assays that have been approved by HVTN laboratory operations.
- Negative for Hepatitis B surface antigen (HBsAg)
- Negative for anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) test if the anti-HCV is positive
- Negative pregnancy test for female participants prior to vaccination on the day of vaccination
- Agreement to avoid pregnancy for female participants, either through abstinence or appropriate use of contraceptives
- If born male, must be fully circumcised (as documented at screening examination)
Who cannot join
- Within the 12 months prior to enrollment: excessive daily alcohol use, frequent binge drinking, chronic marijuana abuse, or any other use of illicit drugs
- Within the 12 months prior to enrollment: a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B virus
- Received non-HIV experimental vaccine(s) within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA. For potential participants who have received the control or placebo in an experimental vaccine trial, the HVTN 084 PSRT will determine eligibility on a case-by-case basis.
- For potential participants who received the control or placebo in an HIV vaccine trial, documentation of the identity of the study control or placebo must be provided to the HVTN 084 protocol safety review team (PSRT), who will determine eligibility on a case-by-case basis.
- Serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain. A participant who had a nonanaphylactic adverse reaction to pertussis vaccine as a child will not be excluded.
- Immunosuppressive medications received within 168 days before first vaccination, except (1) corticosteroid nasal spray for allergic rhinitis, (2) topical corticosteroids for mild, uncomplicated dermatitis, or (3) oral or parenteral corticosteroids given for non-chronic conditions not expected to recur (length of therapy 10 days or less with completion at least 30 days prior to enrollment).
Show all 31Show fewer
- Blood products received within 120 days before first vaccination
- Immunoglobulin received within 60 days before first vaccination
- Live attenuated vaccines other than influenza vaccine received within 30 days before vaccination or scheduled within 14 days after injection (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
- Influenza vaccines or any vaccines that are not live attenuated vaccines (e.g., tetanus, pneumococcal, hepatitis A or B), or allergy treatment with antigen injections that were received within 14 days prior to the vaccination
- Investigational research agents received within 30 days before first vaccination
- Intent to participate in another study of an investigational research agent during the planned duration of the study
- Current anti-tuberculosis (TB) prophylaxis or therapy
- Clinically significant medical condition, physical examination findings, abnormal laboratory results, or past medical history with implications for current health.
- Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent
- Angioedema (hereditary, acquired, or idiopathic) or idiopathic urticaria within the last 3 years if episodes are considered serious or have required medication within the last 2 years
- Autoimmune disease
- Immunodeficiency
- Untreated or incompletely treated syphilis infection
- Asthma other than mild, well-controlled asthma
- Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. History of isolated gestational diabetes does not mandate exclusion.
- Thyroidectomy, or thyroid disease requiring medication during the last 12 months
- Body mass index (BMI) greater than or equal to 40
- Hypertension that is not well controlled
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
- Malignancy. Not excluded: a participant with a surgical excision and subsequent observation period that, in the investigator's estimation, has a reasonable assurance of sustained cure or is unlikely to recur during the period of the study.
- Seizure disorder. Not excluded: a participant with a history of seizures who has not required medications or had a seizure within the past 3 years.
- Asplenia, defined as any condition resulting in the absence of a functional spleen
- Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, persons at ongoing risk for suicide, or persons with a history of suicide attempt or gesture within the past 3 years.
- Pregnant or breastfeeding
- Has been fully circumcised within 90 days prior to first vaccination or displays evidence that surgical site is not fully healed
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States3 sites
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, 02115-6110
Columbia P&S CRS
New York, New York, 10032-3732
New York Blood Center CRS
New York, New York, 10065
Switzerland1 site
Lausanne Vaccine and Immunotherapy Center CRS
Lausanne, Canton of Vaud, 1011
About this study
Official title: A Randomized, Double Blind Phase 1b Trial to Examine the Influence of Antigenic Competition on the Immunogenicity of HIV-1 Gag/Pol: A Comparison of rAd5 Gag/Pol Env A/B/C to rAd5 Gag/Pol
HIV vaccines are designed to create an immune response to certain components of the HIV virus called peptides. Previous research indicates that one peptide, called Gag, may be particularly important for stimulating an immune response to HIV. Many vaccines being studied combine multiple peptides, but including other peptides may weaken the body's response to Gag. This study will test whether a vaccine that targets Gag and another peptide called Env is better than a vaccine without Env at causing an immune response to Gag.
Read the detailed description
HIV vaccines are designed to create an immune response to certain parts of the HIV virus called peptides. Researchers believe that eliciting a response to a peptide called Gag is particularly important. Most HIV vaccines in current clinical trials combine multiple peptides, but including these other peptides may cause antigenic competition. Antigenic competition occurs when the body's immune system reaction to one part of a vaccine weakens or inhibits the response to another part of the vaccine. Specifically, this study is concerned that having too many other peptides in a vaccine might weaken the specific immune response to Gag. This study will test whether a vaccine which only includes the peptides Gag and Pol elicits a stronger immune response to Gag and Pol than a vaccine that also includes the peptides Env A, B, and C.
Participation in this study will last 6 months. The number of study visits will vary by study site. Participants will be randomly assigned to receive injections of one of two vaccines in their upper arm. One group of participants will receive rAd5 gag/pol, which contains only the Gag and Pol peptides, while the other group of participants will receive rAd5 gag/pol Env A/B/C, which contains the Gag, Pol, and Env A, B, and C peptides. For 3 days after injection, participants will need to record their temperature and any side effects, and they will be contacted by study staff 7 days after the injection for follow-up monitoring.
During study visits, participants will complete the following assessments: an HIV test; a physical exam; collection of blood samples; a pregnancy test; and an interview about health, medications, HIV risk behaviors, and experiences with the study.
Participants will be contacted by study staff once a year for 5 years after the vaccination for follow-up health and safety monitoring.
- Conditions
- HIV Infections
- Being tested
- rAd5 Gag-Pol Env A/B/C, rAd5 Gag-Pol
- Keywords
- HIV Preventive Vaccine, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rAd5 Gag-Pol Env A/B/CBiological
1×10^10 particle units (PU) rAd5 Gag-Pol, Env A/B/C (3:1:1:1 mixture) delivered via intramuscular injection
rAd5 Gag-PolBiological
5×10^9 PU rAd5 Gag-Pol delivered via intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Recombinant adenovirus serotype 5 (rAd5) Gag/Pol Env A/B/C | Experimental | Participants will receive one intramuscular injection of rAd5 Gag/Pol Env A/B/C. Receives: Biological: rAd5 Gag-Pol Env A/B/C |
| rAd5 gag/pol | Active comparator | Participants will receive one intramuscular injection of rAd5 gag/pol. Receives: Biological: rAd5 Gag-Pol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of Gag and/or Pol-specific T-cell responses, as measured by Enzyme-Linked Immunospot (ELISpot)
Measured: Measured 4 weeks after immunization
Number of Gag and/or Pol epitopes targeted by CD4+ and CD8+ T-cells, as measured by ELISpot
Measured: Measured 4 weeks after immunization
Secondary outcomes (3)
Number of individuals mounting T-cell responses to Gag and/or Pol, as assessed by ELISpot
Measured: Measured 4 weeks after immunization
Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, adverse events (AEs), and AEs reported on an expedited basis to Division of AIDS (DAIDS)
Measured: Measured over 6 months after immunization
Magnitude of Gag and/or Pol-specific CD4+ and CD8+ T-cell responses, as measured by intracellular cytokine staining (ICS)
Measured: Measured 4 weeks after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completion6 Apr 2017
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 InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Esper Kallas, MD, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159990
- Sponsor's protocol ID
- HVTN 084
- Other IDs
- 10785
- Status last verified
- Oct 2021
- First submitted
- 8 Jul 2010
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
McElrath MJ, De Rosa SC, Moodie Z, Dubey S, Kierstead L, Janes H, Defawe OD, Carter DK, Hural J, Akondy R, Buchbinder SP, Robertson MN, Mehrotra DV, Self SG, Corey L, Shiver JW, Casimiro DR; Step Study Protocol Team. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet. 2008 Nov 29;372(9653):1894-1905. doi: 10.1016/S0140-6736(08)61592-5. Epub 2008 Nov 13.
PubMed 19012957Kiepiela P, Ngumbela K, Thobakgale C, Ramduth D, Honeyborne I, Moodley E, Reddy S, de Pierres C, Mncube Z, Mkhwanazi N, Bishop K, van der Stok M, Nair K, Khan N, Crawford H, Payne R, Leslie A, Prado J, Prendergast A, Frater J, McCarthy N, Brander C, Learn GH, Nickle D, Rousseau C, Coovadia H, Mullins JI, Heckerman D, Walker BD, Goulder P. CD8+ T-cell responses to different HIV proteins have discordant associations with viral load. Nat Med. 2007 Jan;13(1):46-53. doi: 10.1038/nm1520. Epub 2006 Dec 17.
PubMed 17173051
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Phase 1b Trial to Examine the Influence of Antigenic Competition on the Immunogenicity of HIV-1 Gag/Pol: A Comparison of rAd5 Gag/Pol Env A/B/C to rAd5 Gag/Pol
- ClinicalTrials.gov ID
- NCT01159990
- Acronym / sponsor ID
- HVTN 084
- Conditions
- HIV Infections
- Keywords
- HIV Preventive Vaccine, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 12 Jul 2010 (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.
HIV vaccines are designed to create an immune response to certain components of the HIV virus called peptides. Previous research indicates that one peptide, called Gag, may be particularly important for stimulating an immune response to HIV. Many vaccines being studied combine multiple peptides, but including other peptides may weaken the body's response to Gag. This study will test whether a vaccine that targets Gag and another peptide called Env is better than a vaccine without Env at causing an immune response to Gag.
Detailed description
HIV vaccines are designed to create an immune response to certain parts of the HIV virus called peptides. Researchers believe that eliciting a response to a peptide called Gag is particularly important. Most HIV vaccines in current clinical trials combine multiple peptides, but including these other peptides may cause antigenic competition. Antigenic competition occurs when the body's immune system reaction to one part of a vaccine weakens or inhibits the response to another part of the vaccine. Specifically, this study is concerned that having too many other peptides in a vaccine might weaken the specific immune response to Gag. This study will test whether a vaccine which only includes the peptides Gag and Pol elicits a stronger immune response to Gag and Pol than a vaccine that also includes the peptides Env A, B, and C.
Participation in this study will last 6 months. The number of study visits will vary by study site. Participants will be randomly assigned to receive injections of one of two vaccines in their upper arm. One group of participants will receive rAd5 gag/pol, which contains only the Gag and Pol peptides, while the other group of participants will receive rAd5 gag/pol Env A/B/C, which contains the Gag, Pol, and Env A, B, and C peptides. For 3 days after injection, participants will need to record their temperature and any side effects, and they will be contacted by study staff 7 days after the injection for follow-up monitoring.
During study visits, participants will complete the following assessments: an HIV test; a physical exam; collection of blood samples; a pregnancy test; and an interview about health, medications, HIV risk behaviors, and experiences with the study.
Participants will be contacted by study staff once a year for 5 years after the vaccination for follow-up health and safety monitoring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant adenovirus serotype 5 (rAd5) Gag/Pol Env A/B/C | Experimental | Biological: rAd5 Gag-Pol Env A/B/CParticipants will receive one intramuscular injection of rAd5 Gag/Pol Env A/B/C. |
| rAd5 gag/pol | Active comparator | Biological: rAd5 Gag-PolParticipants will receive one intramuscular injection of rAd5 gag/pol. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Access to a participating HIV Vaccine Trials Network (HVTN) Clinical Research Site (CRS) and willingness to be followed for the planned duration of the study
- Completes a questionnaire prior to vaccination that demonstrates an understanding of this study and that in a previous trial there was an association of increased HIV acquisition with receipt of that study vaccine
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks, amenable to HIV risk reduction counseling, and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
- Willingness to continue annual follow-up contact after the last required protocol clinic visit, for a total of 5 years following enrollment
Key exclusion criteria (31 listed)
- Within the 12 months prior to enrollment: excessive daily alcohol use, frequent binge drinking, chronic marijuana abuse, or any other use of illicit drugs
- Within the 12 months prior to enrollment: a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B virus
- Received non-HIV experimental vaccine(s) within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA. For potential participants who have received the control or placebo in an experimental vaccine trial, the HVTN 084 PSRT will determine eligibility on a case-by-case basis.
- For potential participants who received the control or placebo in an HIV vaccine trial, documentation of the identity of the study control or placebo must be provided to the HVTN 084 protocol safety review team (PSRT), who will determine eligibility on a case-by-case basis.
- Serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain. A participant who had a nonanaphylactic adverse reaction to pertussis vaccine as a child will not be excluded.
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 |
|---|---|---|
| rAd5 Gag-Pol Env A/B/C1×10^10 particle units (PU) rAd5 Gag-Pol, Env A/B/C (3:1:1:1 mixture) delivered via intramuscular injection | Biological | Recombinant adenovirus serotype 5 (rAd5) Gag/Pol Env A/B/C |
| rAd5 Gag-Pol5×10^9 PU rAd5 Gag-Pol delivered via intramuscular injection | Biological | rAd5 gag/pol |
Primary outcome
Magnitude of Gag and/or Pol-specific T-cell responses, as measured by Enzyme-Linked Immunospot (ELISpot)
Time frame: Measured 4 weeks after immunization
Number of Gag and/or Pol epitopes targeted by CD4+ and CD8+ T-cells, as measured by ELISpot
Time frame: Measured 4 weeks after immunization
3 secondary outcomes
Number of individuals mounting T-cell responses to Gag and/or Pol, as assessed by ELISpot
Time frame: Measured 4 weeks after immunization
Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, adverse events (AEs), and AEs reported on an expedited basis to Division of AIDS (DAIDS)
Time frame: Measured over 6 months after immunization
Magnitude of Gag and/or Pol-specific CD4+ and CD8+ T-cell responses, as measured by intracellular cytokine staining (ICS)
Time frame: Measured 4 weeks after immunization
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 15 Oct 2021.
- Background: PubMed 19012957McElrath MJ, De Rosa SC, Moodie Z, Dubey S, Kierstead L, Janes H, Defawe OD, Carter DK, Hural J, Akondy R, Buchbinder SP, Robertson MN, Mehrotra DV, Self SG, Corey L, Shiver JW, Casimiro DR; Step Study Protocol Team. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet. 2008 Nov 29;372(9653):1894-1905. doi: 10.1016/S0140-6736(08)61592-5. Epub 2008 Nov 13.
- Background: PubMed 17173051Kiepiela P, Ngumbela K, Thobakgale C, Ramduth D, Honeyborne I, Moodley E, Reddy S, de Pierres C, Mncube Z, Mkhwanazi N, Bishop K, van der Stok M, Nair K, Khan N, Crawford H, Payne R, Leslie A, Prado J, Prendergast A, Frater J, McCarthy N, Brander C, Learn GH, Nickle D, Rousseau C, Coovadia H, Mullins JI, Heckerman D, Walker BD, Goulder P. CD8+ T-cell responses to different HIV proteins have discordant associations with viral load. Nat Med. 2007 Jan;13(1):46-53. doi: 10.1038/nm1520. Epub 2006 Dec 17.
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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.
Esper Kallas, MD, PhD study chair
University of Sao Paulo
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rAd5 Gag-Pol Env A/B/C and rAd5 Gag-Pol in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 4 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 20 inclusion and 31 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Peru, Brazil, Switzerland. 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. 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?
Magnitude of Gag and/or Pol-specific T-cell responses, as measured by Enzyme-Linked Immunospot (ELISpot) (time frame: Measured 4 weeks after immunization). The study lists 2 primary outcomes in all. 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 NCT01159990, 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 15 Oct 2021.