Delving into the Latest Updates on Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

IVACFLU-A

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

influenza A subtype H5N1 infectionInfluenza A virus infectionInfluenza in Birds+ [1]

Originator Organization

Institute Vaccines Medical Biologicals

Active Organization-

Inactive Organization

Institute Of Vaccines And Medical Biologicals, VietnamInstitute Vaccines Medical Biologicals

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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BACKGROUNDA global shortfall of vaccines for avian influenza A(H5N1) would occur, especially in low- and-middle income countries, if a pandemic were to occur. To address this issue, development of a pre-pandemic influenza vaccine was initiated in 2012, leveraging a recently established influenza vaccine manufacturing capacity in Vietnam.METHODSThis was a Phase 2/3, double-blinded, randomized, placebo-controlled study to test the safety and immunogenicity of IVACFLU-A/H5N1 vaccine in healthy adults. Phase 2 was a dose selection study, in which 300 participants were randomized to one of the three groups (15 mcg, 30 mcg, or placebo). Safety and immunogenicity were assessed in all participants. In Phase 3, 630 participants were randomized to receive the IVACFLU-A/H5N1 vaccine dose selected in Phase 2 (15 mcg, n = 525) or placebo (n = 105). Safety was assessed in all Phase 3 participants and immunogenicity was measured in a subset of participants.RESULTSThe vaccine was well tolerated and most of the adverse events were mild and of short duration. Mild pain at the injection site was the most common adverse event seen in 60 percent of participants in the vaccine group in Phase 3. In Phase 2, both 15 mcg and 30 mcg doses were immunogenic, so the lower dose was selected for further testing in Phase 3. In Phase 3 overall seroconversion rates were 68 percent for hemagglutination inhibition (HI), 51 percent for microneutralization (MN) and 56 percent for single radial hemolysis (SRH). The seroprotection rates were 44 percent for HI, 41 percent for MN and 55 percent for SRH. The GMT ratio was 5.31 and 3.7 for HI and MN respectively; GMA was 4.75 for the SRH.CONCLUSIONThe IVACFLU A/H5N1 was safe and immunogenic. Development of this pandemic avian influenza vaccine is a welcome addition to the limited global pool of these vaccines. ClinicalTrials.gov register NCT02612909.

02 Dec 2019·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

A phase 2/3 double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a seasonal trivalent inactivated split-virion influenza vaccine (IVACFLU-S) in healthy adults in Vietnam

Q3 · MEDICINE

Article

Author: Toan, Nguyen Trong ; Francesco, Berlanda Scorza ; Nga, Nguyen Tuyet ; Thai, Duong Huu ; Be, Le Van ; Tang, Yuxiao ; Huong, Vu Minh ; Thang, Tran Cong ; Holt, Renee ; Thang, Hoang Anh ; Lan, Phan Trong ; Flores, Jorge ; Tewari, Tushar

Background: Under the WHO's Global Action Plan for influenza vaccines, we conducted a phase 2-3 study of IVACFLU-S, a trivalent, seasonal inactivated influenza vaccine candidate.Methods: In the phase 2 portion of the study, 252 participants received one dose of 15 mcg hemagglutinin (HA) vaccine per strain or placebo. Following determination of safety, 636 additional participants were randomized in phase 3 to receive vaccine or placebo. Immunogenicity was assessed in a subset of the participants in the phase 3 study.Results: Higher proportion (70%) of participants in the IVACFLU-S arm reported solicited local adverse events (AEs) (p < .0001) as compared to placebo (25%). Mild injection site pain and tenderness were most common AEs seen in 55% and 60% of participants in the vaccine group. The solicited systemic AEs were comparable (p = .4149). The majority of solicited and unsolicited AEs were mild to moderate in severity. In the vaccine arm for the combined age group of 18-60 years of age, seroconversion against antigens A/H1N1, A/H3N2, and B was achieved in 70.3%, 76.1%, and 54.1% of participants respectively; seroprotection against antigens A/H1N1, A/H3N2, and B was achieved in 83.3%, 86.6%, and 60.3% of participants respectively; and the geometric mean fold rise for the hemagglutinin-inhibition (HI) antibody titers against antigen A/H1N1, A/H3N2, and B were 13.15, 11.85, and 5.87, respectively.Conclusion: This study demonstrates the local reactogenicity, other safety, and immunogenicity of IVACFLU-S, first domestically produced influenza vaccine in Vietnam.ClinicalTrials.gov number NCT03095599 (March 29, 2017).

01 Oct 2016·VaccineQ3 · MEDICINE

Randomized safety and immunogenicity trial of a seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) in healthy young Vietnamese adults

Q3 · MEDICINE

Article

Author: Nga, Nguyen Tuyet ; Thiem, Vu Dinh ; Thang, Tran Cong ; Huong, Vu Minh ; Anh, Nguyen Thi Hien ; Holt, Renee ; Berlanda Scorza, Francesco ; Anh, Dang Duc ; Thai, Duong Huu ; Wahid, Rahnuma ; Chien, Vien Chinh ; Taylor, David N ; Flores, Jorge

BACKGROUNDUnder the auspices of the World Health Organization (WHO) Global Action Plan, PATH supported evaluation of a trivalent, seasonal inactivated influenza vaccine candidate produced by the Institute of Vaccines and Medical Biologicals (IVAC), a Vietnamese manufacturer.METHODSIn 2015, 60 healthy adult subjects 18-45years of age were enrolled in a Phase 1, single center, double blind, randomized, placebo-controlled study conducted at a district health center in Thai Binh Province, Vietnam. The study evaluated the overall safety and immunogenicity of a seasonal, trivalent inactivated split virion influenza vaccine. Volunteers were given either vaccine or placebo in a randomized 1:1 ratio. After undergoing screening, eligible volunteers provided their signed consent and were enrolled in the study. On the first day of immunization, randomly chosen volunteers received IVACFLU-S 15μg (mcg) hemagglutinin of each of the three strains in 0.5mL or placebo by intramuscular injection. All volunteers were monitored for adverse events and underwent blood testing at screening and Day 8 to assess the vaccine candidate's safety. Sera obtained before and 21days after immunization were tested for influenza antibody titers using the hemagglutination-inhibition (HAI) and microneutralization tests (MNT).RESULTSVaccine was well tolerated, and there were no serious adverse events reported. HAI and MNT identified serum antibody responses against the three influenza strains in nearly all volunteers who received the vaccine. Overall, serum HAI responses of fourfold or greater were observed in 93 percent, 83 percent, and 77 percent of H1, H3, and B strains, respectively. Seroprotection rates were also very high.CONCLUSIONSIVAC's seasonal, trivalent influenza vaccine was safe and well tolerated and induced high levels of seroconversion and seroprotection rates. These clinical data are a first step towards demonstrating the feasibility of producing the vaccine locally and that seasonal vaccine production in Vietnam may be an effective strategy for enhancing the global influenza vaccine supply. ClinicalTrials.gov number NCT02598089, October 15, 2015.

100 Deals associated with Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza in Birds	Phase 3	VN	Institute Of Vaccines And Medical Biologicals, Vietnam	07 Mar 2017
Influenza, Human	Phase 3	VN	Institute Of Vaccines And Medical Biologicals, Vietnam	07 Mar 2017
influenza A subtype H5N1 infection	Phase 3	VN	Institute Of Vaccines And Medical Biologicals, Vietnam	01 Jun 2014
Influenza A virus infection	Phase 3	-	Institute Vaccines Medical Biologicals	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02612909 (Pubmed \| Vaccine) Manual	Phase 2/3	-	930	IVACFLU-A/H5N1	phhdvsjmqr(etvnocrnno) = plbnyipsxd lcrxjvqeib (fhadelqdot ) View more	Positive	05 Feb 2020
NCT02612909 (CTgov)	Phase 2/3	Influenza in Birds \| Influenza, Human	930	Placebo (Phase 2: Placebo)	fwfgrbhznl(vcbhoudgnl) = ksyooyyswj yiomksdnzp (icetegmzfw, hukduhcjop - jdabtdpwvz) View more	-	16 Apr 2019
				IVACFLU-A/H5N1 vaccine (Phase 2: Vaccine (15 mcg))	fwfgrbhznl(vcbhoudgnl) = kavqvhlgtq yiomksdnzp (icetegmzfw, xsuxmiqnhd - cuqibublhw) View more
NCT01507779 (CTgov)	Phase 1	Influenza A virus infection	48	Placebo (Placebo)	aijbydpkpg(dnzhfpxqbe) = gzkinrsrwh yqjbhmbjgl (wtwibxdmih, hkdlwxsald - tmqldkuclt) View more	-	27 Feb 2019
				IVACFLU (Influenza Vaccine)	aijbydpkpg(dnzhfpxqbe) = ivqixqfbwq yqjbhmbjgl (wtwibxdmih, yoyfxibced - mwwreclgkf) View more