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

Hipra

Status and phase

Completed

Phase 3

Conditions

SARS CoV 2 Infection

Treatments

Biological: PHH1-V

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05303402

HIPRA-HH-4

Details and patient eligibility

About

A phase 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

Enrollment

241 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.