HIV InfectionsPhase 1NCT00801697
Safety and Immune Response to Preventive HIV Immunization With Adenovirus Serotype 5 or 35 Vector
A Phase 1 study testing DNA Vaccine, rAd35 and rAd5 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial summary
This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults. 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?
- DNA Vaccine, rAd35 and rAd5
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 10 sitesUnited States
- Study dates
- Feb 2009to Apr 2015
- 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
- Good general health
- Access to a participating HVTN clinical research site and willingness to be followed for the duration of the study
- Assessment of understanding, including understanding of Step Study results
- Willing to receive HIV test results
- Willing to discuss HIV infection risks, agree to HIV risk reduction counseling, and willing to continue 5 years of annual follow-up contact
- Willing to commit to maintaining behavior consistent with low risk of HIV exposure through the last required protocol visit
Show all 11Show fewer
- Considered low risk for HIV infection after clinical staff assessment. More information on this criterion can be found in the protocol.
- Certain laboratory values. More information on this criterion can be found in the protocol.
- Negative Hepatitis B surface antigen
- Negative anti-Hepatitis C virus antibodies
- For females, agree to use effective contraception from at least 21 days prior to enrollment through the last protocol visit. More information on this criterion can be found in the protocol.
Who cannot join
- HIV-infected
- Active drug or alcohol abuse within 12 months prior to study entry
- History of newly acquired sexually transmitted infections. More information on this criterion can be found in the protocol.
- Experimental vaccines received within 5 years prior to study entry
- Immunosuppressive medications received within 168 days prior to first vaccination
- Blood products received within 120 days prior to first vaccination
Show all 29Show fewer
- Immunoglobulin received within 60 days prior to first vaccination
- Live attenuated vaccines received within 30 days prior to first vaccination
- Investigational research agents received within 30 days prior to first vaccination
- Intent to participate in another study of an investigational research agent during planned duration of the study
- Any vaccines that not live attenuated vaccines and were received within 14 days prior to first vaccination
- Allergy treatment with antigen injections within 30 days prior to first vaccination or scheduled within 14 days after first vaccination
- Clinically significant medical condition, findings, results, or history with implications for current health. More information on this criterion can be found in the protocol.
- Serious adverse reactions to vaccines
- Autoimmune disease
- Immunodeficiency
- Active Syphilis infection within the past 6 months
- Asthma. More information on this criterion can be found in the protocol.
- Diabetes mellitus
- Thyroidectomy or thyroid disease requiring medication during the last 12 months
- Hypertension. More information on this criterion can be found in the protocol.
- Body mass index greater than 35 or 40. More information on this criterion can be found in the protocol.
- Bleeding disorder
- Malignancy
- Seizure disorder
- Asplenia
- Psychiatric condition that precludes compliance with the protocol
- Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the study
- Pregnant or breastfeeding
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Alabama CRS
Birmingham, Alabama, 35294
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, 02115-6110
Fenway Health (FH) CRS
Boston, Massachusetts, 02215-4302
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, 30030
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, 37232-2582
Columbia P&S CRS
New York, New York, 10032-3732
New York Blood Center CRS
New York, New York, 10065
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, 14642
Bridge HIV CRS
San Francisco, California, 94143
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024
About this study
Official title: A Phase 1B Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenoviral Subtype 35 (rAd35) and Subtype 5 (rAd5) HIV-1 Vaccines When Given as a Heterologous Prime-boost Regimen or as Boosts to a Recombinant DNA Vaccine in Healthy, Ad5-Naïve and Ad5-Exposed, Low Risk, HIV-1 Uninfected Adult Participants
This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.
Read the detailed description
One of the more promising approaches in the development of a preventive HIV vaccine uses a DNA plasmid to prime the immune response to an adenoviral vector boost. This primary purpose of this study is to evaluate the safety, tolerability, and immune response to recombinant adenoviral serotype 35 (rAd35) and serotype 5 (rAD5) HIV-1 vaccines in Ad-5 naive and Ad-5 exposed HIV-uninfected adults.
This study will last approximately 12 months. Participants will include those who are both rAD5-naive and rAD5-exposed and will be stratified into one of four groups. Each group will consist of two arms, one interventional and one control. Participants in Groups 1, 2, and 3 will be rAD5-naive. Participants in Group 4 will be rAD5-exposed.
Participants in Group 1 will receive an injection of rAD35 vaccine or placebo at study entry and an injection of rAD5 vaccine or placebo at Month 6 with nine follow-up visits through Month 12. Participants in Groups 2, 3, and 4 will injections of DNA vaccinations or placebo at study entry and at Months 1 and 2, and an injection of rAD35 vaccine, rAD5 vaccine, or placebo at Month 6 with twelve follow-up visits though Month 12. A physical, questionnaire, and counseling will occur at all visits. Blood and urine collection will occur at most visits. A rectal swab will occur at selected visits. For females, a pregnancy test will occur at all visits.
Participants will be contacted for safety follow-ups after the injection every year for 5 years. Health and adverse events will be recorded. Participants will not need to return to the study clinic unless HIV confirmatory testing is needed.
- Conditions
- HIV Infections
- Being tested
- DNA Vaccine, DNA Vaccine placebo, rAd35, rAd35 placebo, rAd5
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine, Adenovirus
- Medical subject headings
- HIV Infections, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA VaccineBiological
4 mg VRC-HIVDNA044-00-VP administered as 1 mL
DNA Vaccine placeboBiological
1 mL VRC-PBSPLA043-00-VP
rAd35Biological
VRC-HIVADV027-00-VP 1 x 10^10 PU administered as 1 mL
rAd35 placeboBiological
1 mL VRC-PBSPLA043-00-0VP
rAd5Biological
4 mg VRC-HIVADV038-00-VP administered as 1 mL
rAd5 placeboBiological
1 mL VRC-DILUENT013-DIL-VP
| Study group | Role | What they receive |
|---|---|---|
| 1A | Experimental | rAD5-naive participants will receive rAd35 intramuscularly at study entry and rAd5 intramuscularly at Month 6 Receives: Biological: rAd35; Biological: rAd5 |
| 1B | Placebo comparator | Participants will receive rAd35 placebo intramuscularly at study entry and rAd5 placebo intramuscularly at Month 6 Receives: Biological: rAd35 placebo; Biological: rAd5 placebo |
| 2A | Experimental | rAD5-naive participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd5 intramuscularly at Month 6 Receives: Biological: DNA Vaccine; Biological: rAd5 |
| 2B | Placebo comparator | Participants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd5 placebo intramuscularly at Month 6 Receives: Biological: DNA Vaccine placebo; Biological: rAd5 placebo |
| 3A | Experimental | Participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd35 intramuscularly at Month 6 Receives: Biological: DNA Vaccine; Biological: rAd35 |
| 3B | Placebo comparator | Participants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd35 placebo intramuscularly at Month 6 Receives: Biological: DNA Vaccine placebo; Biological: rAd35 placebo |
| 4A | Experimental | Participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd35 intramuscularly at Month 6 Receives: Biological: DNA Vaccine; Biological: rAd35 |
| 4B | Placebo comparator | Participants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd35 placebo intramuscularly at Month 6 Receives: Biological: DNA Vaccine placebo; Biological: rAd35 placebo |
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 and expedited adverse events
Measured: Throughout study
Magnitude and frequency of immune responses between HIV-1 clade A env rAD35 and rAd5 vaccines when given as a boost after DNA vaccine
Measured: At Week 4 following the fourth vaccination
Magnitude and frequency of immune responses between clade A env rAD35 vaccine primed by Ad35 versus DNA
Measured: At Week 4 following the last vaccination
Magnitude and frequency of immune responses of HIV-1 clade A env rAD35 vaccine when given as a boost
Measured: At Week 4 following the fourth vaccination
Secondary outcomes (1)
Immunogenicity of HIV-1 clade A env rAD35 vaccine given as a prime
Measured: At Week 4 following the first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 192 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Responsible party
- Sponsor
- Investigators
- Jonathan Fuchs, MD, MPH, Study chair, SFDPH/UCSFPierre-Alexandre Bart, MD, Study chair, CHUV (Lausanne)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801697
- Sponsor's protocol ID
- HVTN 077
- Other IDs
- 10702
- Status last verified
- Oct 2021
- First submitted
- 2 Dec 2008
- Last updated
- 14 Oct 2021
- Results posted
- No
Publications
Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN; Step Study Protocol Team. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29;372(9653):1881-1893. doi: 10.1016/S0140-6736(08)61591-3. Epub 2008 Nov 13.
PubMed 19012954Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81. doi: 10.1086/587993.
PubMed 18433307Sheets RL, Stein J, Bailer RT, Koup RA, Andrews C, Nason M, He B, Koo E, Trotter H, Duffy C, Manetz TS, Gomez P. Biodistribution and toxicological safety of adenovirus type 5 and type 35 vectored vaccines against human immunodeficiency virus-1 (HIV-1), Ebola, or Marburg are similar despite differing adenovirus serotype vector, manufacturer's construct, or gene inserts. J Immunotoxicol. 2008 Jul;5(3):315-35. doi: 10.1080/15376510802312464.
PubMed 18830892Fischinger 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 34843602
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. 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 Recombinant Adenoviral Subtype 35 (rAd35) and Subtype 5 (rAd5) HIV-1 Vaccines When Given as a Heterologous Prime-boost Regimen or as Boosts to a Recombinant DNA Vaccine in Healthy, Ad5-Naïve and Ad5-Exposed, Low Risk, HIV-1 Uninfected Adult Participants
- ClinicalTrials.gov ID
- NCT00801697
- Acronym / sponsor ID
- HVTN 077
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine, Adenovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Dec 2008 (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.
This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.
Detailed description
One of the more promising approaches in the development of a preventive HIV vaccine uses a DNA plasmid to prime the immune response to an adenoviral vector boost. This primary purpose of this study is to evaluate the safety, tolerability, and immune response to recombinant adenoviral serotype 35 (rAd35) and serotype 5 (rAD5) HIV-1 vaccines in Ad-5 naive and Ad-5 exposed HIV-uninfected adults.
This study will last approximately 12 months. Participants will include those who are both rAD5-naive and rAD5-exposed and will be stratified into one of four groups. Each group will consist of two arms, one interventional and one control. Participants in Groups 1, 2, and 3 will be rAD5-naive. Participants in Group 4 will be rAD5-exposed.
Participants in Group 1 will receive an injection of rAD35 vaccine or placebo at study entry and an injection of rAD5 vaccine or placebo at Month 6 with nine follow-up visits through Month 12. Participants in Groups 2, 3, and 4 will injections of DNA vaccinations or placebo at study entry and at Months 1 and 2, and an injection of rAD35 vaccine, rAD5 vaccine, or placebo at Month 6 with twelve follow-up visits though Month 12. A physical, questionnaire, and counseling will occur at all visits. Blood and urine collection will occur at most visits. A rectal swab will occur at selected visits. For females, a pregnancy test will occur at all visits.
Participants will be contacted for safety follow-ups after the injection every year for 5 years. Health and adverse events will be recorded. Participants will not need to return to the study clinic unless HIV confirmatory testing is needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1A | Experimental | Biological: rAd35, Biological: rAd5rAD5-naive participants will receive rAd35 intramuscularly at study entry and rAd5 intramuscularly at Month 6 |
| 1B | Placebo comparator | Biological: rAd35 placebo, Biological: rAd5 placeboParticipants will receive rAd35 placebo intramuscularly at study entry and rAd5 placebo intramuscularly at Month 6 |
| 2A | Experimental | Biological: DNA Vaccine, Biological: rAd5rAD5-naive participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd5 intramuscularly at Month 6 |
| 2B | Placebo comparator | Biological: DNA Vaccine placebo, Biological: rAd5 placeboParticipants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd5 placebo intramuscularly at Month 6 |
| 3A | Experimental | Biological: DNA Vaccine, Biological: rAd35Participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd35 intramuscularly at Month 6 |
| 3B | Placebo comparator | Biological: DNA Vaccine placebo, Biological: rAd35 placeboParticipants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd35 placebo intramuscularly at Month 6 |
| 4A | Experimental | Biological: DNA Vaccine, Biological: rAd35Participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd35 intramuscularly at Month 6 |
| 4B | Placebo comparator | Biological: DNA Vaccine placebo, Biological: rAd35 placeboParticipants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd35 placebo intramuscularly at Month 6 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Good general health
- Access to a participating HVTN clinical research site and willingness to be followed for the duration of the study
- Assessment of understanding, including understanding of Step Study results
- Willing to receive HIV test results
- Willing to discuss HIV infection risks, agree to HIV risk reduction counseling, and willing to continue 5 years of annual follow-up contact
Key exclusion criteria (29 listed)
- HIV-infected
- Active drug or alcohol abuse within 12 months prior to study entry
- History of newly acquired sexually transmitted infections. More information on this criterion can be found in the protocol.
- Experimental vaccines received within 5 years prior to study entry
- Immunosuppressive medications received within 168 days prior to 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 |
|---|---|---|
| DNA Vaccine4 mg VRC-HIVDNA044-00-VP administered as 1 mL | Biological | 2A, 3A, 4A |
| DNA Vaccine placebo1 mL VRC-PBSPLA043-00-VP | Biological | 2B, 3B, 4B |
| rAd35VRC-HIVADV027-00-VP 1 x 10^10 PU administered as 1 mL | Biological | 1A, 3A, 4A |
| rAd35 placebo1 mL VRC-PBSPLA043-00-0VP | Biological | 1B, 3B, 4B |
| rAd54 mg VRC-HIVADV038-00-VP administered as 1 mL | Biological | 1A, 2A |
| rAd5 placebo1 mL VRC-DILUENT013-DIL-VP | Biological | 1B, 2B |
Primary outcome
Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and expedited adverse events
Time frame: Throughout study
Magnitude and frequency of immune responses between HIV-1 clade A env rAD35 and rAd5 vaccines when given as a boost after DNA vaccine
Time frame: At Week 4 following the fourth vaccination
Magnitude and frequency of immune responses between clade A env rAD35 vaccine primed by Ad35 versus DNA
Time frame: At Week 4 following the last vaccination
Magnitude and frequency of immune responses of HIV-1 clade A env rAD35 vaccine when given as a boost
Time frame: At Week 4 following the fourth vaccination
1 secondary outcome
Immunogenicity of HIV-1 clade A env rAD35 vaccine given as a prime
Time frame: At Week 4 following the first 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 14 Oct 2021.
- Background: PubMed 19012954Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN; Step Study Protocol Team. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29;372(9653):1881-1893. doi: 10.1016/S0140-6736(08)61591-3. Epub 2008 Nov 13.
- Background: PubMed 18433307Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81. doi: 10.1086/587993.
- Background: PubMed 18830892Sheets RL, Stein J, Bailer RT, Koup RA, Andrews C, Nason M, He B, Koo E, Trotter H, Duffy C, Manetz TS, Gomez P. Biodistribution and toxicological safety of adenovirus type 5 and type 35 vectored vaccines against human immunodeficiency virus-1 (HIV-1), Ebola, or Marburg are similar despite differing adenovirus serotype vector, manufacturer's construct, or gene inserts. J Immunotoxicol. 2008 Jul;5(3):315-35. doi: 10.1080/15376510802312464.
- 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.
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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.
Jonathan Fuchs, MD, MPH study chair
SFDPH/UCSF
Pierre-Alexandre Bart, MD study chair
CHUV (Lausanne)
10 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 DNA Vaccine, rAd35 and rAd5 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 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 11 inclusion and 29 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 14 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 10 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?
Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and expedited adverse events (time frame: Throughout study). The study lists 4 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 NCT00801697, which also lists 4 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 14 Oct 2021.