Format

Send to

Choose Destination
Vaccine. 2017 Jan 23;35(4):596-604. doi: 10.1016/j.vaccine.2016.12.027. Epub 2016 Dec 24.

First-in-human safety and immunogenicity investigations of three adjuvanted reduced dose inactivated poliovirus vaccines (IPV-Al SSI) compared to full dose IPV Vaccine SSI when given as a booster vaccination to adolescents with a history of IPV vaccination at 3, 5, 12months and 5years of age.

Author information

1
Center for Clinical and Basic Research (CCBR), Ballerup Byvej 222, 2750 Ballerup, Denmark.
2
Statens Serum Institut, 5 Artillerivej, 2300 Copenhagen S., Denmark.
3
CCBR Vejle, Orla Lehmannsgade 1(3), 7100 Vejle, Denmark.
4
CCBR Aalborg, Hobrovej 42 D(2), 9000 Aalborg, Denmark.
5
Larix A/S, Lyskær 8b, 2730 Herlev, Denmark.
6
Statens Serum Institut, 5 Artillerivej, 2300 Copenhagen S., Denmark. Electronic address: btc@ssi.dk.

Abstract

BACKGROUND:

There is a demand of affordable IPV in the World. Statens Serum Institut (SSI) has developed three reduced dose IPV formulations adsorbed to aluminium hydroxide; 1/3 IPV-Al, 1/5 IPV-Al and 1/10 IPV-Al SSI, and now report the results of the first investigations in humans.

METHODS:

240 Danish adolescents, aged 10-15years, and childhood vaccinated with IPV were booster vaccinated with 1/3 IPV-Al, 1/5 IPV-Al, 1/10 IPV-Al or IPV Vaccine SSI. The booster effects (GMTRs) of the three IPV-Al SSI were compared to IPV Vaccine SSI, and evaluated for non-inferiority.

IMMUNOGENICITY RESULTS:

The pre-vaccination GMTs were similar across the groups; 926 (type 1), 969 (type 2) and 846 (type 3) in the total trial population. The GMTRs by poliovirus type and IPV formulation were: Type 1: 17.0 (1/3 IPV-Al), 13.0 (1/5 IPV-Al), 7.1 (1/10 IPV-Al) and 42.2 (IPV Vaccine SSI). Type 2: 12.5 (1/3 IPV-Al), 13.1 (1/5 IPV-Al), 7.6 (1/10 IPV-Al) and 47.8 (IPV Vaccine SSI). Type 3: 14.5 (1/3 IPV-Al), 16.2 (1/5 IPV-Al), 8.9 (1/10 IPV-Al) and 62.4 (IPV Vaccine SSI) Thus, the three IPV-Al formulations were highly immunogenic, but inferior to IPV Vaccine SSI, in this booster vaccination trial.

SAFETY RESULTS:

No SAE and no AE of severe intensity occurred. 59.2% of the subjects reported at least one AE. Injection site pain was the most frequent AE in all groups; from 24.6% to 43.3%. Injection site redness and swelling frequencies were<5% in most and<10% in all groups. The most frequent systemic AEs were fatigue (from 8.2% to 15.0%) and headache (from 15.0% to 28.3%). Most AEs were of mild intensity. In conclusion, the three IPV-Al SSI were safe in adolescents and the booster effects were satisfactory. ClinicalTrials.gov registration number: NCT02280447.

KEYWORDS:

Affordable IPV; Aluminium hydroxide adjuvant; Dose investigation; IPV dose sparing

PMID:
28027810
PMCID:
PMC5267481
DOI:
10.1016/j.vaccine.2016.12.027
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center