Healthy VolunteersPhase 1NCT01915212
Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
A Phase 1 study testing HSV529 in people with Healthy Volunteers, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause serious infection in newborns and in people with weakened immune systems. It increases the risk of getting an HIV infection and of spreading HIV to someone else. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HSV529
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2013to 6 Mar 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- Aged 18 to 40 years on the day of enrollment.
- In good general health with absence of significant health problems as determined by medical history, physical examination, and laboratory screening performed during screening visits.
- Subject will reside within a 60 mile or less radius from Bethesda, MD during the period of participation in the trial.
- Hemoglobin, hematocrit, white blood cell count, platelet count, serum creatinine, and liver function (ALT, AST, alkaline phosphatase, total bilirubin) screening laboratory results do not fall into the range of values that are Grade 1 or greater as per the toxicity grading scale and IgG level greater than or equal to 600 mg/dl.
- Females subjects must be of non-childbearing potential i.e. surgically sterilized (bilateral tubal ligation, hysterectomy) or, if of child-bearing potential and sexually active with a male partner, she must be willing to use a highly effective method of contraception (e.g., intrauterine device (IUD); oral contraceptives diaphragm or condom in combination with contraceptive foam, jelly or cream; Norplant, DepoProvera, contraceptive skin patch or cervical ring) for at least 30 days prior to vaccination and until 30 days after final vaccination or be in a monogamous relationship with a male partner who has undergone a vasectomy at least 6 months prior to first dose of study agent.
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- Willingness to attend all scheduled visits and able to comply with all trial procedures (e.g., blood draws, completion of diary cards, return for follow-up visits, accessible by phone or pager, able to self-sample for assessment of asymptomatic shedding of HSV, and not planning on moving from study area).
- Negative HIV test result determined with an approved FDA-approved test. Confirmatory testing may be required based on the initial assay used and the result.
- Subject is willing not to use antiviral therapy less than or equal to 2 days before and less than or equal to 3 days after each injection.
- Subject is willing to forgo receipt of a licensed, live vaccine in the 30 days preceding each dose of vaccine or in the 30 days following each dose of vaccine. The inactivated flu vaccine can be used greater than or equal to 14 days before or greater than or equal to 14 days after administration of study vaccine, if this is felt to be necessary.
- Persons who have close contact with infants or immunocompromised individuals agree to avoid such contact for 3 days after each injection.
- Subject must be either HSV-1 IgG antibody positive or negative and HSV-2 IgG antibody positive, HSV-1 IgG antibody positive /HSV-2 IgG antibody negative, or HSV-1/HSV-2 IgG antibody negative as determined by an available commercial immunoassay.
- Subject must be willing to allow storage of blood, swabs of skin or mucosa, biopsies of skin lesions, or, for female subjects, cervicovaginal secretions (if collected) for future research.
- Participation of Women:
- Contraception: The effects of HSV529 on the developing human fetus are unknown. For this reason, females subjects must be of non-childbearing potential i.e. either surgically sterilized (bilateral tubal ligation, hysterectomy) or, if of child-bearing potential and sexually active with a male partner, she must be willing to use a highly effective method of contraception (e.g., intrauterine device (IUD); oral contraceptives diaphragm or condom in combination with contraceptive foam, jelly or cream; Norplant, DepoProvera, contraceptive skin patch or cervical ring) for at least 30 days prior to vaccination and until 1 month after final vaccination or be in a monogamous relationship with a male partner who has undergone a vasectomy at least 6 months prior to first dose of study agent. Females must have a negative urine pregnancy test result prior to injection with HSV529 or placebo. During the course of the study, if a woman becomes pregnant or suspects she is pregnant, she should inform the study staff and her primary care physician immediately.
Who cannot join
- Co-enrollment Guidelines: Co-enrollment in other trials is restricted, other than enrollment into observational studies or into the screening protocol. Study staff should be notified of co-enrollment as it may require the approval by the Principal Investigator.
- An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- Subject is pregnant or lactating OR planning to become pregnant timeframe that begins 30 days prior to the first vaccination and ends 30 days after the third vaccination.
- Body Mass Index greater than 40.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination or or planned participation during the study period up to 6 months after the last dose of vaccine or placebo. The non-interventional follow-up for an earlier study (e.g., long-term surveillance) will be allowed.
- Severe active infection or serious HSV-2 related or unrelated medical conditions that, in the opinion of the investigator, would prevent study completion.
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- Subjects with 6 or more symptomatic recurrences of genital herpes disease within the year prior to Day 0.
- A history of HSV infection of the eye (e.g., herpes simplex interstitial keratitis or uveitis).
- A history of herpes gladiatorum, herpetic whitlow or eczema herpeticum.
- A history of lesions caused by HSV on either arm.
- A history of herpes-associated erythema multiforme.
- A history of a clinically significant autoimmune disorder.
- Known or suspected congenital or acquired immunodeficiency
- Receipt of anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
- Subjects using corticosteroids (excluding topical, inhaled or nasal) or any immunomodulating drugs within 42 days prior to the first vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for greater than or equal to 14 days.
- Subjects without a spleen.
- Subjects receiving immunoglobulin within the past 6 months or anticipated receipt of immunoglobulin during the 28 days following vaccination.
- Bleeding disorder, or receipt of anticoagulants that, in the opinion of the Investigator, would interfere with the subject s participation in the trial.
- Prior vaccination against herpes simplex virus.
- Known allergy or intolerance to vaccine components [e.g., potassium glutamate (possible cross-reaction to monosodium glutamate), sucrose] or to a vaccine containing any of the same substances.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol abuse or drug abuse or addiction.
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
- Employee of the NIH or contractor working at the NIH, with direct involvement in the proposed study as well as family members (i.e. immediate, husband, wife and their children, adopted or natural) of the employee or of the investigators of this study.
- Any condition that the PI thinks might compromise the person s ability to comply with the requirements of the study.
- Justification for Exclusion of Women and Children:
- Pregnancy: Pregnant women are excluded from this study because the effects of HSV529 on the developing human fetus are unknown with the potential for teratogenic or abortifacient effects.
- Breast-feeding: Because there is an unknown but potential risk for adverse events in nursing infants secondary to vaccination of the mother with HSV529, breastfeeding should be discontinued if the mother will be vaccinated with HSV529.
- Because there are insufficient data regarding dosing or adverse events available in adults to judge the potential risk in children, children are excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase I Study of the Safety of a Replication-Defective Herpes Simplex Virus-2 Vaccine, HSV529, in Adults Aged 18 to 40 Years With or Without HSV Infection
Background:
- Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause serious infection in newborns and in people with weakened immune systems. It increases the risk of getting an HIV infection and of spreading HIV to someone else. Therefore, a vaccine that could prevent genital herpes could improve the general health of the world s population. Researchers want to study whether a new vaccine, HSV529, which may be used in the future to prevent herpes infections, is safe.
Read more
Objectives:
- To test whether a new herpes vaccine is safe.
Eligibility:
- Healthy adults 18 40 years old.
Design:
- Participants will have 3 vaccination visits, 7 follow-up visits, and 3 follow-up phone calls over 1 year.
- Each vaccination visit will last about 4 hours.
- Participants will be screened with a medical history and physical exam.
- Participants will have a blood sample taken.
- Participants will be given the vaccine or a placebo, by injection from a needle. They will be monitored for 30 minutes to check for any allergic reaction.
- Participants will be given a diary card to record any symptoms they may feel later.
- At follow-up visits, participants will give a blood sample and answer health questions.
- In the phone calls, participants will answer health questions.
Read the detailed description
Herpes simplex virus 2 (HSV-2) causes genital herpes and increases the risk of acquisition and transmission of HIV. An HSV-2 vaccine is not available. We will study a replication-defective HSV-2 vaccine, HSV529, that is deleted for 2 essential viral proteins, that can infect, but not replicate in normal cells. The goals of the study are to determine (a) the safety of HSV529 vaccine in persons with or without HSV infection, and (b) the ability of the vaccine to elicit immune responses to HSV-2 including virus-specific antibodies and T cell responses to the virus. Three groups of 20 subjects each will be randomized and will receive 3 doses of HSV529 (15 subjects per group) or saline placebo injection (5 subjects per group). Each subject will be followed for 6 months after the last dose of vaccine. The 3 groups will be (a) subjects who were infected with HSV-2 in the past but may or may not have been infected with HSV-1 (HSV-1+/-/HSV-2+), (b) subjects who have been infected only with HSV-1 (HSV-1+/HSV-2-), and (c) subjects who have not been infected with HSV-1 or HSV-2 (HSV-1-/HSV-2-). Vaccine or placebo will be administered on Day 0 and approximately 1 month and 6 months after enrollment.
- Conditions
- Healthy Volunteers
- Being tested
- HSV529, Placebo
- Keywords
- Vaccination, Replication Defective, Genital Herpes, Safety, Immune Responses
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSV529Biological
The vaccine was administered intramuscularly (deltoid muscle) as a 0.5 mL solution containing 1 x 10(7) plaque forming units on day 0, one month after the first dose (day 30) and then six months after the first dose (day 180).
PlaceboOther
Sodium Chloride 0.9%
| Study group | Role | What they receive |
|---|---|---|
| HSV529 | Experimental | 1 x 107 pfu/dose of HSV529 in 10 mM L-histidine buffer containing 50 mM potassium glutamate, 160 mM sodium chloride, and 10% (w/v) sucrose Receives: Biological: HSV529 |
| Placebo | Placebo comparator | Sodium Chloride 0.9% Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unsolicited adverse events
Safety
Measured: After the first dose of vaccine to Day 360
Solicited injection site and systemic reactions
Safety
Measured: Day 0 to Day 7 after each dose and up to day 360
Secondary outcomes (1)
Neutralizing antibody levels and T cell-mediated immune responses
Immunogenicity
Measured: After each dose and day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study start26 Sep 2013
- Primary completion6 Mar 2017
- Study completion6 Mar 2017
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 Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Jeffrey I Cohen, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915212
- Sponsor's protocol ID
- 130172
- Other IDs
- 13-I-0172
- Status last verified
- 12 Mar 2026
- First submitted
- 31 Jul 2013
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Da Costa XJ, Jones CA, Knipe DM. Immunization against genital herpes with a vaccine virus that has defects in productive and latent infection. Proc Natl Acad Sci U S A. 1999 Jun 8;96(12):6994-8. doi: 10.1073/pnas.96.12.6994.
PubMed 10359827Hoshino Y, Pesnicak L, Dowdell KC, Burbelo PD, Knipe DM, Straus SE, Cohen JI. Protection from herpes simplex virus (HSV)-2 infection with replication-defective HSV-2 or glycoprotein D2 vaccines in HSV-1-seropositive and HSV-1-seronegative guinea pigs. J Infect Dis. 2009 Oct 1;200(7):1088-95. doi: 10.1086/605645.
PubMed 19702506Da Costa X, Kramer MF, Zhu J, Brockman MA, Knipe DM. Construction, phenotypic analysis, and immunogenicity of a UL5/UL29 double deletion mutant of herpes simplex virus 2. J Virol. 2000 Sep;74(17):7963-71. doi: 10.1128/jvi.74.17.7963-7971.2000.
PubMed 10933704Cheung F, Apps R, Dropulic L, Kotliarov Y, Chen J, Jordan T, Langweiler M, Candia J, Biancotto A, Han KL, Rachmaninoff N, Pietz H, Wang K, Tsang JS, Cohen JI. Sex and prior exposure jointly shape innate immune responses to a live herpesvirus vaccine. Elife. 2023 Jan 17;12:e80652. doi: 10.7554/eLife.80652.
PubMed 36648132Dropulic LK, Oestreich MC, Pietz HL, Laing KJ, Hunsberger S, Lumbard K, Garabedian D, Turk SP, Chen A, Hornung RL, Seshadri C, Smith MT, Hosken NA, Phogat S, Chang LJ, Koelle DM, Wang K, Cohen JI. A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of a Replication-Defective Herpes Simplex Virus (HSV) Type 2 Vaccine, HSV529, in Adults With or Without HSV Infection. J Infect Dis. 2019 Aug 9;220(6):990-1000. doi: 10.1093/infdis/jiz225.
PubMed 31058977
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety of a Replication-Defective Herpes Simplex Virus-2 Vaccine, HSV529, in Adults Aged 18 to 40 Years With or Without HSV Infection
- ClinicalTrials.gov ID
- NCT01915212
- Acronym / sponsor ID
- 130172
- Conditions
- Healthy Volunteers
- Keywords
- Vaccination, Replication Defective, Genital Herpes, Safety, Immune Responses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- 26 Sep 2013 (actual)
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 2 Aug 2013 (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.
Background:
- Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause serious infection in newborns and in people with weakened immune systems. It increases the risk of getting an HIV infection and of spreading HIV to someone else. Therefore, a vaccine that could prevent genital herpes could improve the general health of the world s population. Researchers want to study whether a new vaccine, HSV529, which may be used in the future to prevent herpes infections, is safe.
Objectives:
- To test whether a new herpes vaccine is safe.
Eligibility:
- Healthy adults 18 40 years old.
Design:
- Participants will have 3 vaccination visits, 7 follow-up visits, and 3 follow-up phone calls over 1 year.
- Each vaccination visit will last about 4 hours.
- Participants will be screened with a medical history and physical exam.
- Participants will have a blood sample taken.
- Participants will be given the vaccine or a placebo, by injection from a needle. They will be monitored for 30 minutes to check for any allergic reaction.
- Participants will be given a diary card to record any symptoms they may feel later.
- At follow-up visits, participants will give a blood sample and answer health questions.
- In the phone calls, participants will answer health questions.
Detailed description
Herpes simplex virus 2 (HSV-2) causes genital herpes and increases the risk of acquisition and transmission of HIV. An HSV-2 vaccine is not available. We will study a replication-defective HSV-2 vaccine, HSV529, that is deleted for 2 essential viral proteins, that can infect, but not replicate in normal cells. The goals of the study are to determine (a) the safety of HSV529 vaccine in persons with or without HSV infection, and (b) the ability of the vaccine to elicit immune responses to HSV-2 including virus-specific antibodies and T cell responses to the virus. Three groups of 20 subjects each will be randomized and will receive 3 doses of HSV529 (15 subjects per group) or saline placebo injection (5 subjects per group). Each subject will be followed for 6 months after the last dose of vaccine. The 3 groups will be (a) subjects who were infected with HSV-2 in the past but may or may not have been infected with HSV-1 (HSV-1+/-/HSV-2+), (b) subjects who have been infected only with HSV-1 (HSV-1+/HSV-2-), and (c) subjects who have not been infected with HSV-1 or HSV-2 (HSV-1-/HSV-2-). Vaccine or placebo will be administered on Day 0 and approximately 1 month and 6 months after enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSV529 | Experimental | Biological: HSV5291 x 107 pfu/dose of HSV529 in 10 mM L-histidine buffer containing 50 mM potassium glutamate, 160 mM sodium chloride, and 10% (w/v) sucrose |
| Placebo | Placebo comparator | Other: PlaceboSodium Chloride 0.9% |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- Aged 18 to 40 years on the day of enrollment.
- In good general health with absence of significant health problems as determined by medical history, physical examination, and laboratory screening performed during screening visits.
- Subject will reside within a 60 mile or less radius from Bethesda, MD during the period of participation in the trial.
- Hemoglobin, hematocrit, white blood cell count, platelet count, serum creatinine, and liver function (ALT, AST, alkaline phosphatase, total bilirubin) screening laboratory results do not fall into the range of values that are Grade 1 or greater as per the toxicity grading scale and IgG level greater than or equal to 600 mg/dl.
Key exclusion criteria (29 listed)
- Co-enrollment Guidelines: Co-enrollment in other trials is restricted, other than enrollment into observational studies or into the screening protocol. Study staff should be notified of co-enrollment as it may require the approval by the Principal Investigator.
- An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- Subject is pregnant or lactating OR planning to become pregnant timeframe that begins 30 days prior to the first vaccination and ends 30 days after the third vaccination.
- Body Mass Index greater than 40.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination or or planned participation during the study period up to 6 months after the last dose of vaccine or placebo. The non-interventional follow-up for an earlier study (e.g., long-term surveillance) will be allowed.
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 |
|---|---|---|
| HSV529The vaccine was administered intramuscularly (deltoid muscle) as a 0.5 mL solution containing 1 x 10(7) plaque forming units on day 0, one month after the first dose (day 30) and then six months after the first dose (day 180). | Biological | HSV529 |
| PlaceboSodium Chloride 0.9% | Other | Placebo |
Primary outcome
Unsolicited adverse events
Time frame: After the first dose of vaccine to Day 360
Safety
Solicited injection site and systemic reactions
Time frame: Day 0 to Day 7 after each dose and up to day 360
Safety
1 secondary outcome
Neutralizing antibody levels and T cell-mediated immune responses
Time frame: After each dose and day 360
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 26 Oct 2026.
- Background: PubMed 10359827Da Costa XJ, Jones CA, Knipe DM. Immunization against genital herpes with a vaccine virus that has defects in productive and latent infection. Proc Natl Acad Sci U S A. 1999 Jun 8;96(12):6994-8. doi: 10.1073/pnas.96.12.6994.
- Background: PubMed 19702506Hoshino Y, Pesnicak L, Dowdell KC, Burbelo PD, Knipe DM, Straus SE, Cohen JI. Protection from herpes simplex virus (HSV)-2 infection with replication-defective HSV-2 or glycoprotein D2 vaccines in HSV-1-seropositive and HSV-1-seronegative guinea pigs. J Infect Dis. 2009 Oct 1;200(7):1088-95. doi: 10.1086/605645.
- Background: PubMed 10933704Da Costa X, Kramer MF, Zhu J, Brockman MA, Knipe DM. Construction, phenotypic analysis, and immunogenicity of a UL5/UL29 double deletion mutant of herpes simplex virus 2. J Virol. 2000 Sep;74(17):7963-71. doi: 10.1128/jvi.74.17.7963-7971.2000.
- Derived from this study: PubMed 36648132Cheung F, Apps R, Dropulic L, Kotliarov Y, Chen J, Jordan T, Langweiler M, Candia J, Biancotto A, Han KL, Rachmaninoff N, Pietz H, Wang K, Tsang JS, Cohen JI. Sex and prior exposure jointly shape innate immune responses to a live herpesvirus vaccine. Elife. 2023 Jan 17;12:e80652. doi: 10.7554/eLife.80652.
- Derived from this study: PubMed 31058977Dropulic LK, Oestreich MC, Pietz HL, Laing KJ, Hunsberger S, Lumbard K, Garabedian D, Turk SP, Chen A, Hornung RL, Seshadri C, Smith MT, Hosken NA, Phogat S, Chang LJ, Koelle DM, Wang K, Cohen JI. A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of a Replication-Defective Herpes Simplex Virus (HSV) Type 2 Vaccine, HSV529, in Adults With or Without HSV Infection. J Infect Dis. 2019 Aug 9;220(6):990-1000. doi: 10.1093/infdis/jiz225.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Jeffrey I Cohen, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 HSV529 in people with Healthy Volunteers, 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 15 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 26 Oct 2026. 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?
Unsolicited adverse events (time frame: After the first dose of vaccine to Day 360). 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 NCT01915212, 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 26 Oct 2026.