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Virus Therapy
COVID-19 Vaccine for COVID-19 (HORIZON 1 Trial)
Phase 2
Waitlist Available
Research Sponsored by Janssen Vaccines & Prevention B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from birth up to 2 and 6 months
Awards & highlights
HORIZON 1 Trial Summary
This trial will study the safety and effectiveness of a single dose of Ad26.COV2.S given to pregnant women in their second or third trimester, and potentially post-partum. Researchers will also study the immune response of these women 28 days after vaccination.
Eligible Conditions
- Coronavirus Prevention
HORIZON 1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from birth up to 2 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from birth up to 2 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with AEs leading to Discontinuation
Number of Participants with Adverse Events of Special Interest (AESIs)
Number of Participants with Medically-attended Adverse Events (MAAEs)
+5 moreSecondary outcome measures
Group 4: Number of Adult Participants with AESIs Throughout the Study (From Booster Vaccination Until EOS)
Group 4: Number of Adult Participants with MAAEs Until 6 Months After Booster Vaccination
Group 4: Number of Adult Participants with SAEs Throughout the Study (From Booster Vaccination Until End of the Study [EOS])
+17 moreSide effects data
From 2023 Phase 3 trial • 44325 Patients • NCT045057222%
Headache
2%
Chills
1%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ad26.COV2.S
Placebo
HORIZON 1 Trial Design
1Treatment groups
Experimental Treatment
Group I: Groups 1-4: Ad26.COV2.S (One Dose)Experimental Treatment1 Intervention
Participants who are previously vaccinated (Group 1-3) and participants who are vaccine naïve (Group 4) will receive single dose of Ad26.COV2.S vaccine at standard dose level on Day 1. Participants from group 4 who are no longer pregnant may receive single booster dose of Ad26.COV2.S vaccine at standard dose level.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad26.COV2.S
2021
Completed Phase 3
~84050
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Who is running the clinical trial?
Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,134,215 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
135,458 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a condition called capillary leak syndrome in the past.You have a history of serious, long-term, or worsening neurological disorders or seizures, except for when you had seizures caused by high fever when you were a child.You have had a severe allergic reaction or anaphylaxis to vaccines or their ingredients before.You have a medical history or previous pregnancy complications that could increase the risk of complications for you or your baby.
Research Study Groups:
This trial has the following groups:- Group 1: Groups 1-4: Ad26.COV2.S (One Dose)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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