Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2010 Feb 3;28(5):1209-16.
doi: 10.1016/j.vaccine.2009.11.030. Epub 2009 Nov 25.

A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE

Alfred von Krempelhuber  1 , Jens Vollmar, Rolf Pokorny, Petra Rapp, Niels Wulff, Barbara Petzold, Amanda Handley, Lyn Mateo, Henriette Siersbol, Herwig Kollaritsch, Paul Chaplin
Affiliations
Clinical Trial

A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE

Alfred von Krempelhuber et al. Vaccine. .

Abstract

IMVAMUNE is a Modified Vaccinia Ankara (MVA)-based virus that is being developed as a safer 3rd generation smallpox vaccine. In order to determine the optimal dose for further development, a double-blind, randomized Phase II trial was performed testing three different doses of IMVAMUNE in 164 healthy volunteers. All three IMVAMUNE doses displayed a favourable safety profile, with local reactions as the most frequent observation. The 1 x 10(8)TCID(50) IMVAMUNE dose induced a total antibody response in 94% of the subjects following the first vaccination and the highest peak seroconversion rates by ELISA (100%) and PRNT (71%). This IMVAMUNE dose was considered to be optimal for the further clinical development of this highly attenuated poxvirus as a safer smallpox vaccine.

PubMed Disclaimer

Figures

Figure 1
Figure 1. Disposition of subjects and cohorts analyzed
Out of 273 screened volunteers, 165 subjects were assessed as being eligible for enrolment and allocated to the three study groups. In total, ten subjects were excluded from the per-protocol analysis e.g. due to premature study discontinuation, violation of visit window and seropositivity at study start.
Figure 2
Figure 2. Correlation between the dose of IMVAMUNE® and ELISA and PRNT antibody titres
Subjects were vaccinated on Day 0 and 28 with three different doses of IMVAMUNE® (2×107, 5×107 and 1×108 TCID50) and blood was taken at various intervals and analysed for total and neutralising antibody responses to vaccinia by ELISA and PRNT respectively. The log10 of three different IMVAMUNE® doses was plotted against the log10 of the ELISA (Day 28: 1A, Day 42: 1C) and PRNT titres (Day 28: 1B, Day 42: 1D).
See this image and copyright information in PMC

References

    1. Fenner F, Henderson DA, Arita I, Jezek Z, Ladnyi ID. WHO. Geneva, Switzerland: 1988. Smallpox and its eradication. whqlibdoc.who.int/smallpox/9241561106.pdf.
    1. Monath TP, Caldwell JR, Mundt W, Fusco J, Johnson CS, Buller M, et al. ACAM2000 clonal Vero cell culture vaccinia virus (New York City Board of Health strain)--a second-generation smallpox vaccine for biological defense. Int J Infect Dis. 2004;8(Suppl 2):S31–S44. - PMC - PubMed
    1. Lane JM, Ruben FL, Neff JM, Millar JD. Complications of smallpox vaccination, 1968. N Engl J Med. 1969;281(22):1201–8. - PubMed
    1. Lane JM, Ruben FL, Abrutyn E, Millar JD. Deaths attributable to smallpox vaccination, 1959 to 1966, and 1968. JAMA. 1970;212(3):441–4. - PubMed
    1. Grabenstein JD, Winkenwerder W., Jr. US military smallpox vaccination program experience. JAMA. 2003;289(24):3278–82. - PubMed

Publication types

Substances