Novavax Announces Topline RSV F Vaccine Data from Two Clinical Trials in Older Adults
- Topline data from the Resolve™ Phase 3 trial did not meet pre-specified efficacy objectives
- The attack rate for the Phase 3 primary objective was approximately 25% of that observed in Phase 2 trial
- The attack rate for the Phase 3 primary objective was approximately 25% of that observed in Phase 2 trial
- Topline data from our Phase 2 rollover trial suggest improved vaccine efficacy from a second year of dosing
Management will host a conference call at
Phase 3 Resolve™ Trial
The trial was a randomized, observer-blinded, placebo-controlled trial conducted at 60 sites in
Topline efficacy results of the trial are shown in the following table:
Summary of Primary and Secondary Objectives – Vaccine Efficacy | ||||
Number of Participants - ITT Population (11,856) | ||||
Primary and Secondary Objectives |
Placebo (5,935) |
Vaccine (5,921) |
Vaccine Efficacy (CI) |
P-Value |
Primary: RSV msLRTD, N(%) | 26 (0.44%) | 28 (0.47%) | -7.9 % (-84, 37) | 0.78 |
Secondary: RSV ARD, N(%) | 117 (1.97%) | 102 (1.72%) | 12.6 % (-14, 33) | 0.32 |
“We are both surprised and disappointed by the outcome of the Resolve trial, which we recently unblinded. Our initial analyses and review of the key aspects of the trial do not indicate issues with trial execution, data collection, data integrity, or drug product quality. We expect to have preliminary immunogenicity data in the coming weeks to further our understanding of the trial results,” said
Phase 2 Rollover Trial
The trial was a randomized, observer-blinded, placebo-controlled rollover trial which enrolled 1,329 older adults from the prior Phase 2 trial, conducted at the same 10 sites in
Topline results of the trial are shown in the following tables:
Summary of Geometric Mean Titer for Anti-F by Visit – ITT Population | ||||||||||||
Number of Participants (1,329) | ||||||||||||
Placebo (2014/15) Placebo (2015/16) (N = 333) |
Vaccine (2014/15) Placebo (2015/16) (N = 328) |
Placebo (2014/15) Vaccine (2015/16) (N = 337) |
Vaccine (2014/15) Vaccine (2015/16) (N = 331) |
|||||||||
Day 0 (baseline) N | 333 | 327 | 336 | 329 | ||||||||
GMEU | 1012.8 | 2293.6 | 962.9 | 2267.3 | ||||||||
95% CI | (922.0,1112.5 | ) | (2091.8, 2514.9 | ) | (869.0,1067.0 | ) | (2076.4, 2475.8 | ) | ||||
Day 28 N | 332 | 325 | 333 | 327 | ||||||||
GMEU | 1019.3 | 2188.7 | 6071.2 | 4489.3 | ||||||||
95% CI | (928.6, 1119.0 | ) | (2005.0, 2389.2 | ) | (5526.9, 6669.0 | ) | (4137.7, 4870.7 | ) | ||||
GMEU: geometric mean ELISA units | ||||||||||||
Summary of Exploratory Efficacy Objective+ | ||||||||||
Number of Participants (1,329) | ||||||||||
Placebo (2014/15) Placebo (2015/16) (N = 333) |
Vaccine (2014/15) Placebo (2015/16) (N = 328) |
Placebo (2014/15) Vaccine (2015/16) (N = 337) |
Vaccine (2014/15) Vaccine (2015/16) (N = 331) |
|||||||
RSV ARD (%) | 8 (2.4%) | 7 (2.1%) | 11 (3.3%) | 2 (0.6%)* | ||||||
RSV ARD Vaccine Efficacy | 11 | % | -36 | % | 75 | % | ||||
msLRTD (%) | 1 (0.3%) | 2 (0.6%) | 2 (0.6%) | 0 | ||||||
*p-value = 0.079; msLRTD was not calculated due to low N value | ||||||||||
+all data in table is not significant (p-value > 0.05); preliminary N | ||||||||||
“While the results from the Resolve trial are unexpected, we continue to believe in our technology and product candidates based on the totality of the data from our RSV F Vaccine franchise,” said
Conference call
A replay of the conference call will be available starting at
About RSV
Respiratory syncytial virus, commonly referred to as RSV, is a respiratory infectious disease that causes serious infection of the respiratory tract, similar to influenza. For some, RSV may progress in severity, and lead to hospitalization or even death. The spread of RSV occurs annually, with an incidence rate of 2.5 million infections per year in the
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References
1. A.R. Falsey et al. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med. 2005; 352:1749–59.
2. A.R. Falsey et al. Respiratory syncytial virus and influenza A infections in the hospitalized elderly. J. Infect Dis. 1995; 172:389-94.
3. K. Widmer et al. Rates of hospitalizations for respiratory syncytial virus, human metapneumovirus, and influenza virus in older adults. J Infect Dis. 2012; 206: 56-62.
4. K. Widmer et al. Respiratory syncytial virus & human metapneumovirus-associated emergency department and hospital burden in adults. Influenza and Other Respiratory Viruses. 2014; 8(3): 347-352.
Forward-Looking Statements
Statements herein relating to the future of
Contact:Novavax, Inc. Barclay A. Phillips SVP, Chief Financial Officer and TreasurerAndrea N. Flynn , Ph.D. Associate Director, Investor Relations ir@novavax.com 240-268-2000Russo Partners, LLC David Schull Todd Davenport , Ph.D. david.schull@russopartnersllc.com todd.davenport@russopartnersllc.com 212-845-4271