Clinical trial NCT03356561: A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, First-in-Human Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2017-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 5\*10\^10 viral particles (vp) and 1\*10\^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Participant must be healthy, without significant medical illness, on the basis of physical examination, medical history, and vital signs performed at screening
* Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges, and additionally within the limits representing Food and Drug Administration (FDA) toxicity Grade 1, the participant may be considered eligible only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Participant must agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after the last study vaccine administration
* Participant must be willing to provide verifiable identification
* All female participants of childbearing potential must have:

  1. a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening
  2. a negative urine (beta-hCG) pregnancy test immediately prior to each study vaccine administration

Exclusion Criteria:

* Participant has a known history of flavivirus infection or previous receipt of flavivirus vaccine such as dengue virus (DENV) types 1-4, yellow fever virus (YFV), Japanese encephalitis virus (JEV), and West Nile virus (WNV)
* Participant has traveled to an area with active flavivirus transmission (as per Centers for Disease Control and Prevention \[CDC\]'s 'Zika travel notices') or Zika cautionary areas ('Yellow and Red areas') within 4 weeks before screening
* Participant has chronic active hepatitis B or hepatitis C virus infection, verified at screening by hepatitis B surface antigen (HBsAg) or hepatitis C antibody, respectively
* Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
* Participant received or plans to receive licensed live-attenuated vaccines within 28 days before or after each planned study vaccine administration; licensed inactivated, subunit, or conjugate vaccines within 14 days before or after each planned study vaccine administration

Primary outcomes:
measure: Number of Participants with Solicited Injection Site (Local) Adverse Events (AEs)
timeFrame: 7 days post vaccination on Day 1 (Day 1 up to Day 8)
measure: Number of Participants with Solicited Injection Site (Local) Adverse Events (AEs)
timeFrame: 7 days post vaccination on Day 57 (Day 57 up to Day 64)
measure: Number of Participants with Solicited Systemic AEs
timeFrame: 7 days post vaccination on Day 1 (Day 1 up to Day 8)
measure: Number of Participants with Solicited Systemic AEs
timeFrame: 7 days post vaccination on Day 57 (Day 57 up to Day 64)
measure: Number of Participants with Unsolicited AEs
timeFrame: 28 days post vaccination on Day 1 (Day 1 up to Day 29)
measure: Number of Participants with Unsolicited AEs
timeFrame: 28 days post vaccination on Day 57 (Day 57 up to Day 85)
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: First vaccination to the end of the study (approximately up to 12 months)
measure: Number of Participants with Immediate Reportable Events (IREs)
timeFrame: First vaccination to the end of the study (approximately up to 12 months)
Secondary outcomes:
measure: Neutralizing Antibodies to the Vaccine Strain (or Other Strain)
timeFrame: Days 1, 8, 15, 29, 57, 64, 71, 85, 239, and 365
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Johnson County Clinical Trials
state: Kansas
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Salisch NC, Stephenson KE, Williams K, Cox F, van der Fits L, Heerwegh D, Truyers C, Habets MN, Kanjilal DG, Larocca RA, Abbink P, Liu J, Peter L, Fierro C, De La Barrera RA, Modjarrad K, Zahn RC, Hendriks J, Cahill CP, Leyssen M, Douoguih M, van Hoof J, Schuitemaker H, Barouch DH. A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study of Ad26.ZIKV.001, an Ad26-Vectored Anti-Zika Virus Vaccine. Ann Intern Med. 2021 May;174(5):585-594. doi: 10.7326/M20-5306. Epub 2021 Feb 16.