NCT05016934

Brief Summary

Randomized controlled trial to evaluate safety, immunogenicity and efficacy of three different doses (10, 25 and 50 mcg) of a novel vaccine compared with placebo in adult volunteers previously immunized against Covid-19 with other vaccines \[Corona Vac (Sinovac), ChAdOx1 (AZ 1222, Astra Zeneca) or Ad26.Co2.S (Janssen)\].

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_1 covid19

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

August 19, 2021

Last Update Submit

August 24, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

  • Frequency and severity of local and systemic adverse events

    From day 1 until day 7 after each vaccine or placebo administration

  • Frequency and severity of adverse events of special interest

    From day 1 until day 43

Secondary Outcomes (6)

  • Quantification of interferon gamma producing T lymphocytes (INF-γ) in specific response

    At days 29, 43, 91, 181 and 366

  • Total quantification of CD4 and CD8 T lymphocytes specific to the S1 peptide library

    At days 29, 43, 91, 181 and 366

  • Quantification of CD4 and CD8 T lymphocytes producing specific Th1 (INF-γ, tumor necrosis factor (TNF-α) and IL-2) and Th2 (IL-4, IL-10 and IL-13) intracellular cytokines to the S1 peptide library

    At days 29, 43, 91, 181 and 366

  • Geometric mean titer (GMT) of IgG antibody to protein S1 compared to placebo

    At days 29, 43, 91, 181 and 366

  • Percentage of subjects with virus neutralizing antibody (NAb) in all vaccinated cases compared to placebo

    At days 29, 43, 91, 181 and 366

  • +1 more secondary outcomes

Study Arms (4)

A vaccine composed of a recombinant S1 antigen 10mcg

EXPERIMENTAL

Two applications of 10mcg of a vaccine composed of a recombinant S1 antigen 28 days apart

Biological: A vaccine composed of a recombinant S1 antigen

A vaccine composed of a recombinant S1 antigen 25mcg

EXPERIMENTAL

Two applications of a vaccine composed of a recombinant S1 antigen 28 days apart

Biological: A vaccine composed of a recombinant S1 antigen

A vaccine composed of a recombinant S1 antigen 50mcg

EXPERIMENTAL

Two applications of 50mcg of a vaccine composed of a recombinant S1 antigen 28 days apart

Biological: A vaccine composed of a recombinant S1 antigen

Placebo

PLACEBO COMPARATOR

Two applications of placebo 28 days apart

Biological: A vaccine composed of a recombinant S1 antigen

Interventions

A vaccine composed of a recombinant S1 antigenBIOLOGICAL

Two applications of three different doses of a vaccine composed of a recombinant S1 antigen, a subunit of SARS-CoV-2 virus S protein

A vaccine composed of a recombinant S1 antigen 10mcgA vaccine composed of a recombinant S1 antigen 25mcgA vaccine composed of a recombinant S1 antigen 50mcgPlacebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Previously totally immunized, I.e., two doses for Corona Vac (Sinovac) or ChAdOx1 (AZ 1222, Astra Zeneca, and one dose for Ad26.Co2.S (Janssen) vaccines at least three months before enrollment
  • Negative RT-PCR for SARS-CoV-2 at the moment of triage
  • No previous history of laboratory confirmed Covid-19

You may not qualify if:

  • Pregnancy
  • Participation in other vaccine trial
  • Active decompensated chronic condition, namely, cardiovascular, respiratory, neurological, metabolic or hepatic diseases
  • Any immunocompromise condition (primary immunodeficiencies, auto-immune diseases, long-term use of corticosteroids, solid organ transplant recipients, hematopoietic stem-cell transplant recipients, human-immunodeficiency virus active infection)
  • Active cancer
  • Hepatitis B or C
  • History of allergic reactions to any vaccine component, including excipients and preservatives (neomycin, streptomycin, polymyxin B, eggs
  • Blood donation in the past 4 weeks before screening
  • Received blood product in the past 3 months before screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 23, 2021

Study Start

November 1, 2021

Primary Completion

March 4, 2022

Study Completion

April 20, 2022

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share