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COVID-19 Vaccine for COVID-19 (HORIZON 1 Trial)
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.
- Coronavirus Prevention
HORIZON 1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 44325 Patients • NCT04505722HORIZON 1 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Groups 1-4: Ad26.COV2.S (One Dose)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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