HIV InfectionsPhase 1NCT00961883
Safety of and Immune Response to Prime/Boost Vaccine Regimens in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adults
A Phase 1 study testing NYVAC-B and rAd5 in people with HIV Infections, run by HIV Vaccine Trials Network at 2 sites in Switzerland.
Trial summary
Investigators will examine the safety of and immune responses to two vaccines expressing synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus). The study will compare responses in participants receiving NYVAC-B first, and rAd5 later, to those who receive rAd5 first, and NYVAC-B later. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- NYVAC-B and rAd5
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Aug 2009to Jan 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide informed consent
- Assessment of understanding, including understanding of the Step Study results
- Willingness to receive HIV test results
- Amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
- Assessed by clinic staff as being "low risk" for HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment. More information on this criterion is in the study protocol.
- Good general health
Show all 19Show fewer
- Neutralizing antibody titers of Ad5 less than 1:18
- Hemoglobin count of 11.0 g/dL or more for female volunteers, and 13.0 g/dL or more for male volunteers
- White blood cell count of 3300 to 12000 cells/mm^3
- Total lymphocyte count of 800 cells/mm^3 or more
- Remaining differential either within institutional normal range or with site physician approval
- Platelets in the range of 125,000 to 550,000/mm^3
- Chemistry panel: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and creatinine values less than or equal to the institutional upper limits of normal
- HIV-uninfected
- Negative Hepatitis B surface antigen (HBsAg)
- Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
- Normal urine
- Not pregnant
- A volunteer who was born female must agree to consistently use effective contraception from at least 21 days prior to enrollment through the last protocol visit for sexual activity that could lead to pregnancy
Who cannot join
- Excessive alcohol use or chronic marijuana use, or any other illicit drug use within the 12 months prior to enrollment
- History of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, within the 12 months prior to enrollment
- HIV vaccine received in a prior HIV vaccine trial. For potential participants who have received control/placebo in an HIV vaccine trial, documentation of the identity of the study control/placebo must be provided to the HVTN 078 PSRT, who will determine eligibility on a case-by-case basis.
- Immunosuppressive medications received within 168 days before first vaccination
- Blood products received within 120 days before first vaccination
- Immunoglobulin received within 60 days before first vaccination
Show all 34Show fewer
- Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after first injection
- Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination
- Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first 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 HVTN 078 study
- Current anti-tuberculosis (TB) prophylaxis or therapy
- Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. More information on this criterion is in the study protocol.
- Any medical, psychiatric, or social condition, or occupational or other responsibility 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
- Serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain
- Active syphilis infection
- Allergy to eggs and/or egg products
- History of, or known active cardiac disease
- Participants who have 2 or more specified cardiac risk factors as defined by the study. More information on this criterion is in the study protocol.
- ECG with clinically significant findings. More information on this criterion is in the study protocol.
- Autoimmune disease
- Immunodeficiency
- Asthma other than mild, well-controlled asthma.
- Diabetes mellitus type 1 or type 2, including cases controlled with diet alone
- Thyroidectomy, or thyroid disease
- Angioedema
- Hypertension
- Body mass index (BMI) equal to 40 and above or 35 and above with at least two of the following: systolic blood pressure greater than 140 mm Hg, diastolic blood pressure more than 90 mm Hg, current smoker, known hyperlipidemia
- Bleeding disorder
- Malignancy
- Seizure disorder
- Asplenia
- Psychiatric condition that precludes compliance with the protocol
- Pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1b Clinical Trial to Evaluate the Safety and Immunogenicity of Heterologous Prime/Boost Vaccine Regimens (NYVAC-B/rAd5 vs. rAd5/NYVAC-B) in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adult Participants
Investigators will examine the safety of and immune responses to two vaccines expressing synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus). The study will compare responses in participants receiving NYVAC-B first, and rAd5 later, to those who receive rAd5 first, and NYVAC-B later. A different dose of rAd5 will be tested in each group.
Read the detailed description
In order to halt the HIV pandemic an effective vaccine must be developed. In this study, investigators will examine the safety and immune response to a prime-boost strategy using two different vaccine regimens, NYVAC-B and rAd5.
Eighty participants will be recruited to this study. Participants will be randomly assigned to one of four different groups (study arms). Each group will receive both study vaccines and placebo but at different times. All NYVAC-B vaccine doses will be the same, but the doses of the rAD5 vaccine will differ from group to group. Some participants in each group will receive only placebo. Participants will visit the study clinic about 13 times over the course of 12 months and be contacted for follow-up for 4 years.
All study injections will be given in the same upper arm area. There will be a total of four injections during the course of the study. After each injection, participants will need to stay in the clinic for at least 25 minutes to check for any adverse reactions. Additionally, participants will need to monitor their own health on the evening after the injection and for the next three evenings, by taking their temperature and making notes of any noticed side effects. Tools will be provided to accomplish both of these tasks. During these few days following the injection, study investigators will need to maintain contact with participants (the participant will specify the best mode of contact).
Certain clinical procedures will be performed during the course of this study including regular HIV testing and counseling, physical exams, collection of blood and urine, pregnancy tests if applicable, questions about health and medications, questions about HIV risk and sexual behaviors, and any personal problems or benefits participants may have experienced from participating in the study.
- Conditions
- HIV Infections
- Being tested
- NYVAC-B, Placebo, rAd5
- Keywords
- HIV, Vaccine, HIV Seronegativity, Preventive Vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NYVAC-BBiological
New York Vaccinia (NYVAC) vector for HIV-1, delivered intramuscularly by injection at a dose of 1 x 10 ^7 PFU
PlaceboBiological
Sodium Chloride for injection, delivered intramuscularly
rAd5Biological
Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^10 PFU
rAd5Biological
Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^9 PFU
rAd5Biological
Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^8 PFU
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Thirty participants will receive injections in the following order: NYVAC-B for injections one and two, placebo for injection three, and rAd5 for the fourth and final injection. Two participants in this group will receive placebo vaccines only. Receives: Biological: NYVAC-B; Biological: Placebo; Biological: rAd5 |
| 2 | Experimental | Fifteen participants will receive injections in the following order: rAd5 for injection one, placebo for injection two, and NYVAC-B for injections three and four. One participant in this group will receive placebo vaccines only. Receives: Biological: NYVAC-B; Biological: Placebo; Biological: rAd5 |
| 3 | Experimental | Fifteen participants will receive injections in the following order: rAd5 for injection one, placebo for injection two, and NYVAC-B for injections three and four. One participant in this group will receive placebo vaccines only. Receives: Biological: NYVAC-B; Biological: Placebo; Biological: rAd5 |
| 4 | Experimental | Fifteen participants will receive injections in the following order: rAd5 for injection one, placebo for injection two, and NYVAC-B for injections three and four. One participant in this group will receive placebo vaccines only. Receives: Biological: NYVAC-B; Biological: Placebo; Biological: rAd5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse events and serious adverse events meeting expedited adverse (EAE) criteria
Measured: Throughout study
Secondary outcomes (1)
Magnitude and frequency of T-cell response as measured by ELISpot and/or intracellular cytokine staining (ICS) assay 2 weeks post 4th vaccination
Measured: At 2 Weeks following 4th Vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- HIV Vaccine Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), EuroVacc Foundation
- Responsible party
- Sponsor
- Investigators
- Giuseppe Pantaleo, Study chair, CTU LausannePierre-Alexandre Bart, MD, Study chair, Lausanne CRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961883
- Sponsor's protocol ID
- HVTN 078
- Other IDs
- 5U01AI068614
- Status last verified
- Sep 2013
- First submitted
- 17 Aug 2009
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gomez CE, Najera JL, Jimenez EP, Jimenez V, Wagner R, Graf M, Frachette MJ, Liljestrom P, Pantaleo G, Esteban M. Head-to-head comparison on the immunogenicity of two HIV/AIDS vaccine candidates based on the attenuated poxvirus strains MVA and NYVAC co-expressing in a single locus the HIV-1BX08 gp120 and HIV-1(IIIB) Gag-Pol-Nef proteins of clade B. Vaccine. 2007 Apr 12;25(15):2863-85. doi: 10.1016/j.vaccine.2006.09.090. Epub 2006 Oct 16.
PubMed 17113200Harari A, Bart PA, Stohr W, Tapia G, Garcia M, Medjitna-Rais E, Burnet S, Cellerai C, Erlwein O, Barber T, Moog C, Liljestrom P, Wagner R, Wolf H, Kraehenbuhl JP, Esteban M, Heeney J, Frachette MJ, Tartaglia J, McCormack S, Babiker A, Weber J, Pantaleo G. An HIV-1 clade C DNA prime, NYVAC boost vaccine regimen induces reliable, polyfunctional, and long-lasting T cell responses. J Exp Med. 2008 Jan 21;205(1):63-77. doi: 10.1084/jem.20071331. Epub 2008 Jan 14.
PubMed 18195071Liu J, O'Brien KL, Lynch DM, Simmons NL, La Porte A, Riggs AM, Abbink P, Coffey RT, Grandpre LE, Seaman MS, Landucci G, Forthal DN, Montefiori DC, Carville A, Mansfield KG, Havenga MJ, Pau MG, Goudsmit J, Barouch DH. Immune control of an SIV challenge by a T-cell-based vaccine in rhesus monkeys. Nature. 2009 Jan 1;457(7225):87-91. doi: 10.1038/nature07469. Epub 2008 Nov 9.
PubMed 18997770Fischinger S, Cizmeci D, Deng D, Grant SP, Frahm N, McElrath J, Fuchs J, Bart PA, Pantaleo G, Keefer M, O Hahn W, Rouphael N, Churchyard G, Moodie Z, Donastorg Y, Streeck H, Alter G. Sequence and vector shapes vaccine induced antibody effector functions in HIV vaccine trials. PLoS Pathog. 2021 Nov 29;17(11):e1010016. doi: 10.1371/journal.ppat.1010016. eCollection 2021 Nov.
PubMed 34843602Bart PA, Huang Y, Karuna ST, Chappuis S, Gaillard J, Kochar N, Shen X, Allen MA, Ding S, Hural J, Liao HX, Haynes BF, Graham BS, Gilbert PB, McElrath MJ, Montefiori DC, Tomaras GD, Pantaleo G, Frahm N. HIV-specific humoral responses benefit from stronger prime in phase Ib clinical trial. J Clin Invest. 2014 Nov;124(11):4843-56. doi: 10.1172/JCI75894. Epub 2014 Oct 1.
PubMed 25271627
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Clinical Trial to Evaluate the Safety and Immunogenicity of Heterologous Prime/Boost Vaccine Regimens (NYVAC-B/rAd5 vs. rAd5/NYVAC-B) in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adult Participants
- ClinicalTrials.gov ID
- NCT00961883
- Acronym / sponsor ID
- HVTN 078
- Conditions
- HIV Infections
- Keywords
- HIV, Vaccine, HIV Seronegativity, Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- HIV Vaccine Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), EuroVacc Foundation
- Study start
- Aug 2009
- Primary completion
- Jan 2013 (actual)
- First posted
- 19 Aug 2009 (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.
Investigators will examine the safety of and immune responses to two vaccines expressing synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus). The study will compare responses in participants receiving NYVAC-B first, and rAd5 later, to those who receive rAd5 first, and NYVAC-B later. A different dose of rAd5 will be tested in each group.
Detailed description
In order to halt the HIV pandemic an effective vaccine must be developed. In this study, investigators will examine the safety and immune response to a prime-boost strategy using two different vaccine regimens, NYVAC-B and rAd5.
Eighty participants will be recruited to this study. Participants will be randomly assigned to one of four different groups (study arms). Each group will receive both study vaccines and placebo but at different times. All NYVAC-B vaccine doses will be the same, but the doses of the rAD5 vaccine will differ from group to group. Some participants in each group will receive only placebo. Participants will visit the study clinic about 13 times over the course of 12 months and be contacted for follow-up for 4 years.
All study injections will be given in the same upper arm area. There will be a total of four injections during the course of the study. After each injection, participants will need to stay in the clinic for at least 25 minutes to check for any adverse reactions. Additionally, participants will need to monitor their own health on the evening after the injection and for the next three evenings, by taking their temperature and making notes of any noticed side effects. Tools will be provided to accomplish both of these tasks. During these few days following the injection, study investigators will need to maintain contact with participants (the participant will specify the best mode of contact).
Certain clinical procedures will be performed during the course of this study including regular HIV testing and counseling, physical exams, collection of blood and urine, pregnancy tests if applicable, questions about health and medications, questions about HIV risk and sexual behaviors, and any personal problems or benefits participants may have experienced from participating in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: NYVAC-B, Biological: Placebo, Biological: rAd5Thirty participants will receive injections in the following order: NYVAC-B for injections one and two, placebo for injection three, and rAd5 for the fourth and final injection. Two participants in this group will receive placebo vaccines only. |
| 2 | Experimental | Biological: NYVAC-B, Biological: Placebo, Biological: rAd5Fifteen participants will receive injections in the following order: rAd5 for injection one, placebo for injection two, and NYVAC-B for injections three and four. One participant in this group will receive placebo vaccines only. |
| 3 | Experimental | Biological: NYVAC-B, Biological: Placebo, Biological: rAd5Fifteen participants will receive injections in the following order: rAd5 for injection one, placebo for injection two, and NYVAC-B for injections three and four. One participant in this group will receive placebo vaccines only. |
| 4 | Experimental | Biological: NYVAC-B, Biological: Placebo, Biological: rAd5Fifteen participants will receive injections in the following order: rAd5 for injection one, placebo for injection two, and NYVAC-B for injections three and four. One participant in this group will receive placebo vaccines only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Willing and able to provide informed consent
- Assessment of understanding, including understanding of the Step Study results
- Willingness to receive HIV test results
- Amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
- Assessed by clinic staff as being "low risk" for HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment. More information on this criterion is in the study protocol.
Key exclusion criteria (34 listed)
- Excessive alcohol use or chronic marijuana use, or any other illicit drug use within the 12 months prior to enrollment
- History of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, within the 12 months prior to enrollment
- HIV vaccine received in a prior HIV vaccine trial. For potential participants who have received control/placebo in an HIV vaccine trial, documentation of the identity of the study control/placebo must be provided to the HVTN 078 PSRT, who will determine eligibility on a case-by-case basis.
- Immunosuppressive medications received within 168 days before first vaccination
- Blood products received within 120 days before first 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 |
|---|---|---|
| NYVAC-BNew York Vaccinia (NYVAC) vector for HIV-1, delivered intramuscularly by injection at a dose of 1 x 10 ^7 PFU | Biological | 1, 2, 3, 4 |
| PlaceboSodium Chloride for injection, delivered intramuscularly | Biological | 1, 2, 3, 4 |
| rAd5Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^10 PFU | Biological | 1, 4 |
| rAd5Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^9 PFU | Biological | 3 |
| rAd5Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^8 PFU | Biological | 2 |
Primary outcome
Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse events and serious adverse events meeting expedited adverse (EAE) criteria
Time frame: Throughout study
1 secondary outcome
Magnitude and frequency of T-cell response as measured by ELISpot and/or intracellular cytokine staining (ICS) assay 2 weeks post 4th vaccination
Time frame: At 2 Weeks following 4th Vaccination
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 6 Sep 2013.
- Background: PubMed 17113200Gomez CE, Najera JL, Jimenez EP, Jimenez V, Wagner R, Graf M, Frachette MJ, Liljestrom P, Pantaleo G, Esteban M. Head-to-head comparison on the immunogenicity of two HIV/AIDS vaccine candidates based on the attenuated poxvirus strains MVA and NYVAC co-expressing in a single locus the HIV-1BX08 gp120 and HIV-1(IIIB) Gag-Pol-Nef proteins of clade B. Vaccine. 2007 Apr 12;25(15):2863-85. doi: 10.1016/j.vaccine.2006.09.090. Epub 2006 Oct 16.
- Background: PubMed 18195071Harari A, Bart PA, Stohr W, Tapia G, Garcia M, Medjitna-Rais E, Burnet S, Cellerai C, Erlwein O, Barber T, Moog C, Liljestrom P, Wagner R, Wolf H, Kraehenbuhl JP, Esteban M, Heeney J, Frachette MJ, Tartaglia J, McCormack S, Babiker A, Weber J, Pantaleo G. An HIV-1 clade C DNA prime, NYVAC boost vaccine regimen induces reliable, polyfunctional, and long-lasting T cell responses. J Exp Med. 2008 Jan 21;205(1):63-77. doi: 10.1084/jem.20071331. Epub 2008 Jan 14.
- Background: PubMed 18997770Liu J, O'Brien KL, Lynch DM, Simmons NL, La Porte A, Riggs AM, Abbink P, Coffey RT, Grandpre LE, Seaman MS, Landucci G, Forthal DN, Montefiori DC, Carville A, Mansfield KG, Havenga MJ, Pau MG, Goudsmit J, Barouch DH. Immune control of an SIV challenge by a T-cell-based vaccine in rhesus monkeys. Nature. 2009 Jan 1;457(7225):87-91. doi: 10.1038/nature07469. Epub 2008 Nov 9.
- Derived from this study: PubMed 34843602Fischinger S, Cizmeci D, Deng D, Grant SP, Frahm N, McElrath J, Fuchs J, Bart PA, Pantaleo G, Keefer M, O Hahn W, Rouphael N, Churchyard G, Moodie Z, Donastorg Y, Streeck H, Alter G. Sequence and vector shapes vaccine induced antibody effector functions in HIV vaccine trials. PLoS Pathog. 2021 Nov 29;17(11):e1010016. doi: 10.1371/journal.ppat.1010016. eCollection 2021 Nov.
- Derived from this study: PubMed 25271627Bart PA, Huang Y, Karuna ST, Chappuis S, Gaillard J, Kochar N, Shen X, Allen MA, Ding S, Hural J, Liao HX, Haynes BF, Graham BS, Gilbert PB, McElrath MJ, Montefiori DC, Tomaras GD, Pantaleo G, Frahm N. HIV-specific humoral responses benefit from stronger prime in phase Ib clinical trial. J Clin Invest. 2014 Nov;124(11):4843-56. doi: 10.1172/JCI75894. Epub 2014 Oct 1.
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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.
Giuseppe Pantaleo study chair
CTU Lausanne
Pierre-Alexandre Bart, MD study chair
Lausanne CRS
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 NYVAC-B and rAd5 in people with HIV Infections, run by HIV Vaccine Trials Network at 2 sites in Switzerland.
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 19 inclusion and 34 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 6 Sep 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 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?
Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse events and serious adverse events meeting expedited adverse (EAE) criteria (time frame: Throughout study). 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 NCT00961883, which also lists 5 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 6 Sep 2013.