Public Statement from EuroVacc Foundation and IDT Biologika, Switzerland, Germany, May 13, 2015

GENEVA--()--Volunteers in HIV vaccine clinical trials in Switzerland and the US are being asked to return for medical follow-up. On May 4, 2015 clinical trial material of a candidate HIV vaccine (NYVAC-HIV-PT1) used in two phase I clinical studies in 2012-2013 was identified as containing a porcine mycoplasma (Mycoplasma hyorhinis). The studies were conducted in Switzerland and the USA and 94 participants who received the NYVAC-HIV-PT1 were exposed to an intramuscular injection containing M. hyorhinis. The EuroVacc Foundation, Switzerland, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, USA, were the sponsors of the clinical trials in Switzerland and the USA, respectively. The clinical studies were conducted under the auspices of the HIV Vaccine Trials Network (HVTN) Seattle, USA. The vaccine was manufactured by IDT Biologika in Germany.

HVTN 092 and HVTN 096 participant safety data collected over the last 18 months as part of the routine post-study follow-up have been closely evaluated and no pattern of adverse events have been reported over this time period among people who received NYVAC. However, through an abundance of caution, study participants are currently being contacted and asked to return to their clinical sites for blood testing and physical examination. A medical plan has been established in connection with this extended follow-up.

This discovery was made following an investigation that started in early 2015 when a new NYVAC-HIV-PT1 lot manufactured by IDT Biologika was shown to contain M. hyorhinis. IDT conducted a look-back investigation for the presence of M. hyorhinis and discovered that the seed lot used for manufacturing the new NYVAC-HIV-PT1 was contaminated with M. hyorhinis. IDT has not seen any such mycoplasma contamination in other human vaccines for commercial or clinical use in more than 10 years. The seed lot found to contain M. hyorhinis was the same one used for manufacturing of the NYVAC-HIV-PT1 vaccine used in HVTN 096 and HVTN 092. The lot manufactured in January has been discarded by IDT.

The detection of M. hyorhinis was possible in 2015 due to the recent development and validation by IDT Biologika of a highly sensitive PCR-based assay. The NYVAC–HIV–PT1 lot utilized in HVTN 096 and HVTN 092 passed mycoplasma sterility testing in 2011 using the then state of the art assays of culture methods for the release of the clinical trial material. These assays revealed no evidence of mycoplasma contamination of the vaccine candidate. The assay documentation was reviewed and accepted by health authorities in both Switzerland (Swissmedic) and the USA (FDA).

M. hyorhinis is a porcine (pig) mycoplasma frequently found in healthy pigs that is not an established cause of human illness. There is no documented seroconversion or medical illnesses specifically associated with M. hyorhinis.

EuroVacc Foundation, NIAID, HVTN and IDT Biologika have taken all the necessary initiatives and agreed to the medical plan to warrant the safety of the participants.

Contacts

Medical issues
HVTN: James Maynard, +1-206-667-5295
jmaynard@fredhutch.org
or
EuroVacc: Song Ding, +31205661595, +31655133756
song.ding@eurovacc.org
or
Manufacturing issues:
IDT Biologika: Dr. Andreas Neubert, +49 172 34 96 447
Andreas.Neubert@idt-biologika.de
or
NIAID: Kathy Stover 301-402-1663
niaidnews@niaid.nih.gov