HIV InfectionsPhase 1NCT01103687
Evaluating the Safety and Immune Response of an Adenovirus-Based HIV Vaccine in HIV-Uninfected Adults
A Phase 1 study testing Ad26.ENVA.01 (rAd26) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and immune response of an adenovirus-based HIV vaccine 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?
- Ad26.ENVA.01 (rAd26)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 2016
- 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
- Willing to be followed for the planned duration of the study
- Able and willing to provide informed consent
- Assessment of understanding, including the completion of a questionnaire prior to vaccination; verbally demonstrated understanding of all questionnaire items answered incorrectly
- Willing to receive HIV test results
- In good general health as shown by medical history, physical exam, and screening laboratory tests
- Hemoglobin levels greater than or equal to 11.0 g/dL for women and greater than or equal to 12.5 g/dL for men
Show all 17Show fewer
- 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 accompanied by site physician approval
- Platelet levels between 125,000 and 550,000/mm3
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin less than 1.25 times the institutional upper limit of normal; and creatinine less than or equal to the institutional upper limit of normal
- Negative HIV-1 and 2 blood test
- 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 test; more information about this criterion can be found in the protocol
- Female participants must have a negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed on the day of vaccination prior to vaccination
- Female participants must agree to consistently use contraception from at least 21 days prior to study entry through the last study visit. More information on this criterion can be found in the protocol.
Who cannot join
- Received HIV vaccine(s) in a prior HIV vaccine trial. Participants who received a control/placebo in an HIV vaccine trial are not excluded but documentation of the identity of the study control/placebo must be obtained.
- Immunosuppressive medications received within 168 days before vaccination (e.g., oral/parenteral corticosteroids, and/or cytotoxic medications). People taking corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
- Blood products received within 120 days before vaccination
- Immunoglobulin received within 60 days before vaccination
- Live attenuated vaccines received within 30 days before vaccination (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; Flumist® influenza)
- Investigational research agents received within 30 days before vaccination
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- Any vaccines that are not live attenuated vaccines and were received within 14 days prior to vaccination (e.g., influenza, tetanus, pneumococcal, Hepatitis A or B)
- 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 can be found in the 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. People who had a nonanaphylactic adverse reaction to the pertussis vaccine as a child are not excluded.
- Known autoimmune disease
- Known immunodeficiency
- Active syphilis infection. People who had syphilis that was fully treated more than 6 months before study entry are not excluded.
- Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
- Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. People with a history of isolated gestational diabetes are not excluded.
- Thyroidectomy, or thyroid disease requiring medication in the 12 months before study entry
- Angioedema in the 3 years before study entry if episodes are considered serious or have required medication in the 2 years before study entry
- If a person has been diagnosed with high blood pressure during screening or previously, they will be excluded for high blood pressure that is not well controlled. If a person has NOT been diagnosed with high blood pressure during screening or previously, they will be excluded for systolic blood pressure greater than or equal to 150 mm Hg at study entry or diastolic blood pressure greater than or equal to 100 mm Hg at study entry.
- Body mass index (BMI) greater than or equal to 40, or BMI greater than or equal to 35 and two or more of the following conditions: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, or known hyperlipidemia
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, platelet disorder requiring special precautions)
- Cancer. People 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 study period are not excluded.
- Seizure disorder or experienced a seizure in the 3 years before study entry. People with a history of seizures who have not required medications or had a seizure in the 3 years before study entry are not excluded.
- Absence of a functional spleen
- Psychiatric condition that makes study compliance difficult (e.g., people with psychoses in the 3 years before study entry, ongoing risk for suicide, history of suicide attempt or gesture in the 3 years before study entry)
- Pregnant or breastfeeding
- Abnormality of the rectum or rectal mucosa, which in the opinion of the clinician represents a contraindication to rectal biopsy
- Use of medication interfering with normal coagulation that may increase the risk for bleeding at the time of the rectal biopsy
- Experimental vaccine(s) received in a prior vaccine trial in the 5 years before study entry. Exceptions may be made for vaccines that are currently licensed or have subsequently undergone licensure. For potential participants who have received control/placebo in an experimental vaccine trial, the protocol safety review team (PSRT) will determine eligibility on a case-by-case basis. For potential participants who have received an experimental vaccine(s) more than 5 years ago, eligibility for enrollment will be determined by the PSRT on a case-by-case basis.
- Men who have sex with men (MSM) who have had receptive anal intercourse in the 12 months before study entry must have a positive rectal gonorrhea or chlamydia test by nucleic acid amplification test (NAAT) or culture
- Perianal herpes simplex virus (HSV) outbreak in the 30 days before study entry
- History of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, HSV2, chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B in the 12 months prior to study entry
- Individuals who are classified as not low-risk for acquisition of HIV-1 infection, on the basis of sexual behaviors within the 12 months prior to study entry. More information on this criterion can be found in the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network CRS
Boston, Massachusetts, 02115-6110
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety, Mucosal Immunogenicity and Innate Immune Responses of Recombinant Adenovirus Serotype 26 HIV-1 Vaccine (Ad26.ENVA.01) in Healthy, HIV-1 Uninfected Adults (Ad26.ENVA.01 (rAd26) HIV-1 Mucosal/IPCAVD-003 Vaccine Study)
The purpose of this study is to evaluate the safety and immune response of an adenovirus-based HIV vaccine in HIV-uninfected adults.
Read the detailed description
Control of the global HIV pandemic will require the development of a safe and effective vaccine. Many HIV preventive vaccines that are in development use a recombinant adenovirus serotype 5 (rAd5) vector as a way of delivering the vaccine into cells. However, the majority of people, particularly in the developing world, have immunity against the Ad5 vector, which means the vaccine will not be effective at preventing HIV infection. This study will use a rAd26 vector as part of a HIV vaccine, as research has shown that relatively few people have immunity against this vector. The purpose of this study is to evaluate the safety and immunogenicity of a rAd26 vector preventive HIV-1 vaccine.
This study will enroll healthy, HIV-uninfected people. Participants will be randomly assigned to receive either the rAd26 vaccine or a placebo vaccine. All vaccines will be injected into the upper arm. At the vaccination study visit, participants will undergo a medical and medication history review, physical examination, and a rectal sampling procedure. They will then receive their assigned vaccine. After receiving the vaccine, participants will remain in the clinic for at least 30 minutes for observation and monitoring of side effects. Participants will receive counseling on HIV risk reduction and pregnancy prevention. For 7 days after the vaccination, participants will monitor their temperature and side effects. Additional study visits will occur at Days 1, 3, 7, 14, 28, 61, 168, and 365. At these visits, participants will undergo a medical history review, physical examination, counseling, and blood collection. At the Day 14 and 168 visits, a rectal sampling procedure will be performed. Participants will attend a study visit or be contacted by study researchers by telephone or e-mail 18 months after receiving the vaccine for follow-up health and safety monitoring. Participants may elect to attend optional follow-up visits for blood collection at Years 2, 3, 4, and 5.
- Conditions
- HIV Infections
- Being tested
- Ad26.ENVA.01 (rAd26), Placebo Vaccine
- Keywords
- HIV 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.
Ad26.ENVA.01 (rAd26)Biological
5 x 10^10 virus particles (VP) vaccine delivered intramuscularly (IM)
Placebo VaccineBiological
Also called FFB, final formula buffer
Placebo vaccine delivered IM
| Study group | Role | What they receive |
|---|---|---|
| Ad26.ENVA.01 (rAd26) | Experimental | Participants will receive the Ad26.ENVA.01 (rAd26) vaccine at baseline. Receives: Biological: Ad26.ENVA.01 (rAd26) |
| Placebo Vaccine | Placebo comparator | Participants will receive the placebo vaccine at baseline. Receives: Biological: Placebo Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic reactions to vaccine
Measured: Measured through the 18-month follow-up visit
Adverse and serious adverse experiences
Measured: Measured through the 18-month follow-up visit
Secondary outcomes (5)
Innate immune responses, including cytokine levels and natural killer (NK) cell populations
Measured: Measured through the 18-month follow-up visit
Humoral immune responses, including neutralizing antibodies against HIV and Ad26 and binding antibodies
Measured: Measured through the 18-month follow-up visit
Cell mediated immunity, including T-cell gamma interferon responses by enzyme-linked immunosorbent spot (ELISPOT) and T-cell responses by flow cytometry
Measured: Measured through the 18-month follow-up visit
Mucosal immune responses, including histopathology and T-cell responses by flow cytometry
Measured: Measured through the 18-month follow-up visit
Genotyping
Measured: Measured through the 18-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lindsey Baden, Study chair, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103687
- Sponsor's protocol ID
- Ad26.ENVA.01 Mucosal/IPCAVD003
- Other IDs
- 11678, Ad26.ENVA.01 Mucosal, Ad26.ENVA.01Mucosal/IPCAVD-003
- Status last verified
- Sep 2017
- First submitted
- 13 Apr 2010
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mast TC, Kierstead L, Gupta SB, Nikas AA, Kallas EG, Novitsky V, Mbewe B, Pitisuttithum P, Schechter M, Vardas E, Wolfe ND, Aste-Amezaga M, Casimiro DR, Coplan P, Straus WL, Shiver JW. International epidemiology of human pre-existing adenovirus (Ad) type-5, type-6, type-26 and type-36 neutralizing antibodies: correlates of high Ad5 titers and implications for potential HIV vaccine trials. Vaccine. 2010 Jan 22;28(4):950-7. doi: 10.1016/j.vaccine.2009.10.145. Epub 2009 Nov 17.
PubMed 19925902Priddy 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 18433307Baden LR, Liu J, Li H, Johnson JA, Walsh SR, Kleinjan JA, Engelson BA, Peter L, Abbink P, Milner DA Jr, Golden KL, Viani KL, Stachler MD, Chen BJ, Pau MG, Weijtens M, Carey BR, Miller CA, Swann EM, Wolff M, Loblein H, Seaman MS, Dolin R, Barouch DH. Induction of HIV-1-specific mucosal immune responses following intramuscular recombinant adenovirus serotype 26 HIV-1 vaccination of humans. J Infect Dis. 2015 Feb 15;211(4):518-28. doi: 10.1093/infdis/jiu485. Epub 2014 Aug 26.
PubMed 25165165
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety, Mucosal Immunogenicity and Innate Immune Responses of Recombinant Adenovirus Serotype 26 HIV-1 Vaccine (Ad26.ENVA.01) in Healthy, HIV-1 Uninfected Adults (Ad26.ENVA.01 (rAd26) HIV-1 Mucosal/IPCAVD-003 Vaccine Study)
- ClinicalTrials.gov ID
- NCT01103687
- Acronym / sponsor ID
- Ad26.ENVA.01 Mucosal/IPCAVD003
- Conditions
- HIV Infections
- Keywords
- HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Apr 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.
The purpose of this study is to evaluate the safety and immune response of an adenovirus-based HIV vaccine in HIV-uninfected adults.
Detailed description
Control of the global HIV pandemic will require the development of a safe and effective vaccine. Many HIV preventive vaccines that are in development use a recombinant adenovirus serotype 5 (rAd5) vector as a way of delivering the vaccine into cells. However, the majority of people, particularly in the developing world, have immunity against the Ad5 vector, which means the vaccine will not be effective at preventing HIV infection. This study will use a rAd26 vector as part of a HIV vaccine, as research has shown that relatively few people have immunity against this vector. The purpose of this study is to evaluate the safety and immunogenicity of a rAd26 vector preventive HIV-1 vaccine.
This study will enroll healthy, HIV-uninfected people. Participants will be randomly assigned to receive either the rAd26 vaccine or a placebo vaccine. All vaccines will be injected into the upper arm. At the vaccination study visit, participants will undergo a medical and medication history review, physical examination, and a rectal sampling procedure. They will then receive their assigned vaccine. After receiving the vaccine, participants will remain in the clinic for at least 30 minutes for observation and monitoring of side effects. Participants will receive counseling on HIV risk reduction and pregnancy prevention. For 7 days after the vaccination, participants will monitor their temperature and side effects. Additional study visits will occur at Days 1, 3, 7, 14, 28, 61, 168, and 365. At these visits, participants will undergo a medical history review, physical examination, counseling, and blood collection. At the Day 14 and 168 visits, a rectal sampling procedure will be performed. Participants will attend a study visit or be contacted by study researchers by telephone or e-mail 18 months after receiving the vaccine for follow-up health and safety monitoring. Participants may elect to attend optional follow-up visits for blood collection at Years 2, 3, 4, and 5.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ad26.ENVA.01 (rAd26) | Experimental | Biological: Ad26.ENVA.01 (rAd26)Participants will receive the Ad26.ENVA.01 (rAd26) vaccine at baseline. |
| Placebo Vaccine | Placebo comparator | Biological: Placebo VaccineParticipants will receive the placebo vaccine at baseline. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Willing to be followed for the planned duration of the study
- Able and willing to provide informed consent
- Assessment of understanding, including the completion of a questionnaire prior to vaccination; verbally demonstrated understanding of all questionnaire items answered incorrectly
- Willing to receive HIV test results
- In good general health as shown by medical history, physical exam, and screening laboratory tests
Key exclusion criteria (32 listed)
- Received HIV vaccine(s) in a prior HIV vaccine trial. Participants who received a control/placebo in an HIV vaccine trial are not excluded but documentation of the identity of the study control/placebo must be obtained.
- Immunosuppressive medications received within 168 days before vaccination (e.g., oral/parenteral corticosteroids, and/or cytotoxic medications). People taking corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
- Blood products received within 120 days before vaccination
- Immunoglobulin received within 60 days before vaccination
- Live attenuated vaccines received within 30 days before vaccination (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; Flumist® influenza)
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 |
|---|---|---|
| Ad26.ENVA.01 (rAd26)5 x 10^10 virus particles (VP) vaccine delivered intramuscularly (IM) | Biological | Ad26.ENVA.01 (rAd26) |
| Placebo VaccineAlso: FFB, final formula bufferPlacebo vaccine delivered IM | Biological | Placebo Vaccine |
Primary outcome
Local and systemic reactions to vaccine
Time frame: Measured through the 18-month follow-up visit
Adverse and serious adverse experiences
Time frame: Measured through the 18-month follow-up visit
5 secondary outcomes
Innate immune responses, including cytokine levels and natural killer (NK) cell populations
Time frame: Measured through the 18-month follow-up visit
Humoral immune responses, including neutralizing antibodies against HIV and Ad26 and binding antibodies
Time frame: Measured through the 18-month follow-up visit
Cell mediated immunity, including T-cell gamma interferon responses by enzyme-linked immunosorbent spot (ELISPOT) and T-cell responses by flow cytometry
Time frame: Measured through the 18-month follow-up visit
Mucosal immune responses, including histopathology and T-cell responses by flow cytometry
Time frame: Measured through the 18-month follow-up visit
Genotyping
Time frame: Measured through the 18-month follow-up visit
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 8 Sep 2017.
- Background: PubMed 19925902Mast TC, Kierstead L, Gupta SB, Nikas AA, Kallas EG, Novitsky V, Mbewe B, Pitisuttithum P, Schechter M, Vardas E, Wolfe ND, Aste-Amezaga M, Casimiro DR, Coplan P, Straus WL, Shiver JW. International epidemiology of human pre-existing adenovirus (Ad) type-5, type-6, type-26 and type-36 neutralizing antibodies: correlates of high Ad5 titers and implications for potential HIV vaccine trials. Vaccine. 2010 Jan 22;28(4):950-7. doi: 10.1016/j.vaccine.2009.10.145. Epub 2009 Nov 17.
- 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.
- Derived from this study: PubMed 25165165Baden LR, Liu J, Li H, Johnson JA, Walsh SR, Kleinjan JA, Engelson BA, Peter L, Abbink P, Milner DA Jr, Golden KL, Viani KL, Stachler MD, Chen BJ, Pau MG, Weijtens M, Carey BR, Miller CA, Swann EM, Wolff M, Loblein H, Seaman MS, Dolin R, Barouch DH. Induction of HIV-1-specific mucosal immune responses following intramuscular recombinant adenovirus serotype 26 HIV-1 vaccination of humans. J Infect Dis. 2015 Feb 15;211(4):518-28. doi: 10.1093/infdis/jiu485. Epub 2014 Aug 26.
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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.
Lindsey Baden study chair
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ad26.ENVA.01 (rAd26) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 17 inclusion and 32 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 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 reactions to vaccine (time frame: Measured through the 18-month follow-up visit). 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 NCT01103687, which also lists 3 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 8 Sep 2017.