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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 weeks
Treatment ~ Varies
Follow Up ~from birth up to 2 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth up to 2 and 6 months for reporting.

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 more
Secondary 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 more

Side effects data

From 2023 Phase 3 trial • 44325 Patients • NCT04505722
2%
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

Find a Location

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,134,250 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
135,458 Total Patients Enrolled

Media Library

Ad26.COV2.S (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04765384 — Phase 2
Coronavirus Prevention Research Study Groups: Groups 1-4: Ad26.COV2.S (One Dose)
Coronavirus Prevention Clinical Trial 2023: Ad26.COV2.S Highlights & Side Effects. Trial Name: NCT04765384 — Phase 2
Ad26.COV2.S (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04765384 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to join this trial?

"In this medical trial, 51 individuals with covid-19 between the ages of 18 and 45 are being sought. Essential criteria include physical health (confirmed via examination), being in the second or third trimester of pregnancy, not having had an authorized/licensed COVID-19 vaccine for at least 4 months prior to first study vaccination, a stable medication dose over the preceding four weeks, agreement to not donate bone marrow/blood products from first vaccine administration until three months after receiving last dose of study vaccine; additionally participants must be able to provide verifiable identification and have means to contact investigator during trial."

Answered by AI

Are there any vacancies available for this experiment?

"Clinicaltrials.gov indicates that this particular medical trial, which opened its enrollment on August 27th 2021 and closed it on November 22nd 2022, is no longer recruiting patients. However, there are still 1039 other studies actively seeking volunteers at the present time."

Answered by AI

How many participants have been recruited for this research endeavor?

"This trial is no longer recruiting. Originally posted August 27th 2021, and last updated November 22nd 2022, this study has concluded recruitment. For those hoping to participate in a clinical trial related to Covid-19 or Ad26.COV2.S, there are 1031 studies actively looking for patients and 8 trials respectively seeking enrolment at the moment."

Answered by AI

To what degree is Ad26.COV2.S secure for human use?

"Our team at Power allocated a score of 2 to Ad26.COV2.S's safety, as only preliminary data which supports its safety has been gathered in Phase 2 trials without any evidence yet of efficacy."

Answered by AI

Does this research initiative have any contemporary equivalents?

"Presently, 8 Ad26.COV2.S trials are taking place across 19 nations and 130 cities. The first clinical trial began in 2020 under the sponsorship of Janssen Vaccines & Prevention B.V., which studied 1085 patients during Phase 1&2 drug approval stages before concluding its study that year; since then an additional 5 experiments have been completed regarding this medication."

Answered by AI

Can elderly individuals participate in this research endeavor?

"This medical trial has established that 18 years old is the minimum age of eligibility and 45 as the maximum."

Answered by AI

What outcomes is this research endeavor hoping to realize?

"The main outcome of this medical trial, which will be estimated over the course of 7 days post-vaccination or until resolution (spanning up to Day 64), is Serological Response to Vaccination as measured by an Enzyme-linked Immunosorbent Assay. Secondary objectives encompass monitoring Number of Neonates and Infants with Antibody GMT at birth, tracking Group 4 Adult Participants for MAAEs in a 6 month period following any applicable booster vaccinations, and observing Serological Response to Vaccination via Virus Neutralization Assay Titers 28 Days After the Initial Vaccine Dose."

Answered by AI
~27 spots leftby Apr 2025