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November 2, 2023Open Access

Safety and immunogenicity of COReNAPCIN ® , a SARS-CoV-2 mRNA vaccine; a randomized, double-blind, placebo-controlled phase 1 clinical trial

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Key result

COReNAPCIN booster safely induces up to a ~22-fold increase in anti-spike antibodies.

  • n=30

Why the study?

Repeated COVID-19 outbreaks despite global vaccination highlight the need for booster doses.

Does COReNAPCIN booster improve immunogenicity and is it safe in adults previously vaccinated with inactivated vaccines?

Population

30 adults aged 18-50 who had previously received three doses of inactivated vaccines

Comparison

COReNAPCIN (25 μg or 50 μg) vs placebo

Design

Randomized, double-blind, placebo-controlled phase 1 trial

Follow-up

Up until day 90 post vaccination

Authors

MSMohammadreza SalehiImam Khomeini HospitalIDIlad Alavi DarazamYahoo (Spain)ANAlireza NematollahiIsfahan University of Medical Sciences

Discussion

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Implication

Supports COReNAPCIN as a booster option after inactivated vaccines; extends heterologous mRNA boosting data in adults.

Study Design

Type

RCT (n=30)

Blinding

Double-blind

Randomization

2:2:1

Multicenter

No

Structured PICO

Does COReNAPCIN booster improve immunogenicity and is it safe in adults previously vaccinated with inactivated vaccines?

P
Population
30 healthy adults aged 18-50 who had previously received three doses of inactivated COVID-19 vaccines, followed for 90 days post-vaccination to assess the safety and immunogenicity of an mRNA booster.
I
Intervention
COReNAPCIN (SARS-CoV-2 mRNA vaccine) 25 μg or 50 μg as a booster dose
C
Comparator
Placebo
O
Outcome
Safety and immunogenicity (anti-RBD, anti-spike, neutralizing antibodies, T-cell response) up to day 90 post vaccinationsafety

Main Result

Absolute Event Rate: 0% vs 0%

The COReNAPCIN mRNA vaccine booster is safe and highly immunogenic in adults previously vaccinated with inactivated vaccines.

Limitations

  • Small sample size typical of phase 1 trials
  • Vaccine candidate was based on the original Wuhan strain rather than newer variants
  • Short follow-up period of 90 days

Cite This Study

Salehi et al. (2023) conducted an RCT in COVID-19 (booster vaccination) (n=30). COReNAPCIN vs. Placebo (0.9% saline) was evaluated on Serious adverse events. COReNAPCIN was well-tolerated with no serious adverse events and induced up to a 21.7-fold increase in anti-spike antibodies at the 50 µg dose.

synapsesocial.com/papers/6aa94ffc710837438104fb4ahttps://doi.org/10.1101/2023.11.01.23297898
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Also Consider

Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis2021 · 449 citations
  2. 2Persistence of immune response in heterologous COVID vaccination schedules in the Com-COV2 study – A single-blind, randomised trial incorporating mRNA, viral-vector and protein-adjuvant vaccines2023 · 18 citations
  3. 3Reduced neutralisation of the Delta (B.1.617.2) SARS-CoV-2 variant of concern following vaccination2021 · 196 citations
  4. 4A phase I/II randomized, double-blinded, placebo-controlled trial of a self-amplifying Covid-19 mRNA vaccine2022 · 63 citations