A Phase IIb/III Clinical Trial to Assess Safety and Immunogenicity of a COVID-19 Vaccine Booster Dose in Immunosupressed Adults.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2023-12-01

Brief Summary

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A phase IIb/III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19

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WITHDRAWN

Detailed Description

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Conditions

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SARS CoV 2 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose

Intramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose.

Group Type EXPERIMENTAL

PHH-1V

Intervention Type BIOLOGICAL

COVID-19 Vaccine HIPRA, 40 mcg/dose

Interventions

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PHH-1V

COVID-19 Vaccine HIPRA, 40 mcg/dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male, female or transgender, ≥ 18 years old at Day 0.
* Provide inform consent form
* Participant who has:
* 3 doses of mRNA vaccines
* 2 doses of mRNA vaccines and previous COVID-19 infection
* 2 doses of Coronavac and 1 Comirnaty, or, 1 Coronavac and 2 Comirnaty
* Participant who has:
* HIV infection with CD4 Tcells counts \<400
* Primary antibody deficiency disorders
* Kidney disease on dialysis
* Kidney transplant at least \>1 year
* Auto Immune Disease (AID) in treatment with rituximab
* For a female of childbearing potential, to have a negative pregnancy test at Day 0
* Use of any of these contraception:
* Female: hormonal contraception, intrauterine device, vasectomized partner, sexual abstinence, condom.
* Male: Vasectomized participant, sexual abstinence, condom.

Exclusion Criteria

* History of anaphylaxis to any prior vaccine
* Participants has received or plans to receive live attenuated vaccines, other not live vaccines, or Vaxzevria or Janssen vaccines.
* Pregnant or breast-feeding at Day 0.
* A confirmed COVID-19 diagnose \<90 days prior to vaccination day 0.
* A clinically significant acute illness or fever at screening or 48h before day 0.
* Participant had a surgery requiring hospitalisation and has not received the hospital discharge.
* Participant has an ongoing severe and non-stable psychiatric condition
* Participant has a problematic or risky use of substances including alcohol
* Participant has a bleeding disorder that contraindicates intramuscular injection
* Participant suffering from post-acute COVID-19 syndrome / long COVID
* Participant received any immunotherapy to prevent/treat COVID-19 in the last 90 days
* Participant is already participating in another research involving drug, biologics or device
* Participant has donated ≥450 ml of blood products within 12 weeks before screening
* Participant has any medical condition and/or finding that in the investigator opinion might increase participant risk, interfere with the study or impair interpretation of study data.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No