Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03611946|
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Zika Virus||Biological: rZIKV/D4Δ30-713 Biological: Placebo||Phase 1|
This study will evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection.
Participants will be randomly assigned to receive a single dose of either rZIKV/D4Δ30-713 or placebo at study entry (Day 0).
Study visits will occur on Days 0, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, and 180. Visits may include a physical examination; blood, urine, saliva, vaginal secretions, and semen collection; and pregnancy testing.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase I Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults|
|Actual Study Start Date :||July 6, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||September 30, 2019|
Participants will receive a single dose of rZIKV/D4Δ30-713 at study entry (Day 0).
Administered at a dose of 10^3 plaque-forming units (PFUs) by subcutaneous injection
Placebo Comparator: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Administered by subcutaneous injection
- Frequency of solicited local and general adverse events (AEs) [ Time Frame: Measured through Day 28 ]Evaluated using the Adverse Event Grading Table in the study protocol
- Frequency of unsolicited AEs [ Time Frame: Measured through Day 28 ]Evaluated using the Adverse Event Grading Table in the study protocol
- Frequency of medically-attended AEs and serious adverse events (SAEs) [ Time Frame: Measured through Day 90 ]Evaluated using the Adverse Event Grading Table in the study protocol
- Peak neutralizing antibody titer to ZIKV [ Time Frame: Measured through Day 90 ]Determined by seropositivity and seroconversion frequencies
- Frequency of viremia [ Time Frame: Measured through Day 180 ]Measured by tissue culture (infectious virus) and PCR
- Determination of the neutralizing antibody titer to ZIKV [ Time Frame: Measured through Day 180 ]Determined by seropositivity and seroconversion frequencies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611946
|United States, Maryland|
|Johns Hopkins University, Bloomberg School of Public Health||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Jennifer Han 410-955-0054 firstname.lastname@example.org|
|United States, Vermont|
|University of Vermont Medical Center (UVMMC), Clinical Research Center||Recruiting|
|Burlington, Vermont, United States, 05401|
|Contact: Patricia Lutton 802-656-0013 Patricia.email@example.com|
|Principal Investigator:||Anna Durbin, MD||Center for Immunization Research, Johns Hopkins School of Public Health|
|Principal Investigator:||Kristen Pierce, MD||University of Vermont|