Tags

Type your tag names separated by a space and hit enter

Effect of two injections of non-adjuvanted influenza A H1N1pdm2009 vaccine in renal transplant recipients: INSERM C09-32 TRANSFLUVAC trial.
Vaccine. 2012 Dec 14; 30(52):7522-8.V

Abstract

BACKGROUND

Enhancing vaccine immunogenicity in kidney transplant recipients, particularly against influenza, is required since the immunosuppression used to prevent graft rejection limits vaccine immunogenicity. We therefore investigated the immunogenicity and safety of a double dose non-adjuvanted vaccination regimen against influenza H1N1pdm2009 in kidney transplant adult recipients.

METHODS

A prospective single-arm study was conducted including 121 renal transplant recipients under triple immunosuppressive regimen. Patients received 2 injections (day 0, day 21) of an inactivated, non-adjuvanted H1N1pdm2009 vaccine. Immunogenicity (hemagglutination-inhibition [HI] antibodies and anti-hemagglutin [HA] specific T cells) was evaluated after one and two injections (day 21, day 42) and at 6 months (day 182).

RESULTS

The seroprotection rate (HI antibody titer≥1/40) was 19% at day 0 (n=119), 53% at day 21 (n=118), 60% at day 42 (n=116) (p=0.013; day 42 vs. day 21) and 56% at day 182 (n=113). The seroconversion rate was 24% and 32%, the geometric mean fold rise was 3.7 and 4.6 after the first and second injections, respectively. T-cell immunity to the H1N1pdm2009 vaccine showed a two-fold increase from baseline, though not statistically significant, in H1N1pdm2009-HA-specific CD4+ and CD8+ T cells in 34% and 48% of cases, respectively. No rejection episodes related to vaccination were observed while the donor-specific antibodies and creatinine clearance remained unchanged throughout the study.

CONCLUSION

Administration of two doses of the non-adjuvanted influenza H1N1pdm2009 vaccine in renal transplant patients is safe and induces a significant seroprotection, not strong enough yet to meet European or US requirements for adults below 60 years, but comparable to seroprotection levels usually observed in the non immunosuppressed elderly population or conferred by a single dose of adjuvanted vaccine in solid organ transplant recipients. These results provide useful indications for future strategies required to improve immunogenicity of vaccines against influenza in transplanted patients.

Authors+Show Affiliations

INSERM UMRS-945, Laboratoire Immunité et Infection, Groupe Hospitalier Pitié-Salpêtrière Paris, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23103195

Citation

Le Corre, Nicole, et al. "Effect of Two Injections of Non-adjuvanted Influenza a H1N1pdm2009 Vaccine in Renal Transplant Recipients: INSERM C09-32 TRANSFLUVAC Trial." Vaccine, vol. 30, no. 52, 2012, pp. 7522-8.
Le Corre N, Thibault F, Pouteil Noble C, et al. Effect of two injections of non-adjuvanted influenza A H1N1pdm2009 vaccine in renal transplant recipients: INSERM C09-32 TRANSFLUVAC trial. Vaccine. 2012;30(52):7522-8.
Le Corre, N., Thibault, F., Pouteil Noble, C., Meiffrédy, V., Daoud, S., Cahen, R., Charreau, I., Bottigioli, D., Dollinger, C., Aboulker, J. P., Autran, B., Morelon, E., & Barrou, B. (2012). Effect of two injections of non-adjuvanted influenza A H1N1pdm2009 vaccine in renal transplant recipients: INSERM C09-32 TRANSFLUVAC trial. Vaccine, 30(52), 7522-8. https://doi.org/10.1016/j.vaccine.2012.10.047
Le Corre N, et al. Effect of Two Injections of Non-adjuvanted Influenza a H1N1pdm2009 Vaccine in Renal Transplant Recipients: INSERM C09-32 TRANSFLUVAC Trial. Vaccine. 2012 Dec 14;30(52):7522-8. PubMed PMID: 23103195.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of two injections of non-adjuvanted influenza A H1N1pdm2009 vaccine in renal transplant recipients: INSERM C09-32 TRANSFLUVAC trial. AU - Le Corre,Nicole, AU - Thibault,Fréderic, AU - Pouteil Noble,Claire, AU - Meiffrédy,Vincent, AU - Daoud,Sameh, AU - Cahen,Remi, AU - Charreau,Isabelle, AU - Bottigioli,David, AU - Dollinger,Cécile, AU - Aboulker,Jean-Pierre, AU - Autran,Brigitte, AU - Morelon,Emmanuel, AU - Barrou,Benoit, Y1 - 2012/10/25/ PY - 2012/07/10/received PY - 2012/10/03/revised PY - 2012/10/13/accepted PY - 2012/10/30/entrez PY - 2012/10/30/pubmed PY - 2013/4/30/medline SP - 7522 EP - 8 JF - Vaccine JO - Vaccine VL - 30 IS - 52 N2 - BACKGROUND: Enhancing vaccine immunogenicity in kidney transplant recipients, particularly against influenza, is required since the immunosuppression used to prevent graft rejection limits vaccine immunogenicity. We therefore investigated the immunogenicity and safety of a double dose non-adjuvanted vaccination regimen against influenza H1N1pdm2009 in kidney transplant adult recipients. METHODS: A prospective single-arm study was conducted including 121 renal transplant recipients under triple immunosuppressive regimen. Patients received 2 injections (day 0, day 21) of an inactivated, non-adjuvanted H1N1pdm2009 vaccine. Immunogenicity (hemagglutination-inhibition [HI] antibodies and anti-hemagglutin [HA] specific T cells) was evaluated after one and two injections (day 21, day 42) and at 6 months (day 182). RESULTS: The seroprotection rate (HI antibody titer≥1/40) was 19% at day 0 (n=119), 53% at day 21 (n=118), 60% at day 42 (n=116) (p=0.013; day 42 vs. day 21) and 56% at day 182 (n=113). The seroconversion rate was 24% and 32%, the geometric mean fold rise was 3.7 and 4.6 after the first and second injections, respectively. T-cell immunity to the H1N1pdm2009 vaccine showed a two-fold increase from baseline, though not statistically significant, in H1N1pdm2009-HA-specific CD4+ and CD8+ T cells in 34% and 48% of cases, respectively. No rejection episodes related to vaccination were observed while the donor-specific antibodies and creatinine clearance remained unchanged throughout the study. CONCLUSION: Administration of two doses of the non-adjuvanted influenza H1N1pdm2009 vaccine in renal transplant patients is safe and induces a significant seroprotection, not strong enough yet to meet European or US requirements for adults below 60 years, but comparable to seroprotection levels usually observed in the non immunosuppressed elderly population or conferred by a single dose of adjuvanted vaccine in solid organ transplant recipients. These results provide useful indications for future strategies required to improve immunogenicity of vaccines against influenza in transplanted patients. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/23103195/Effect_of_two_injections_of_non_adjuvanted_influenza_A_H1N1pdm2009_vaccine_in_renal_transplant_recipients:_INSERM_C09_32_TRANSFLUVAC_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)01493-4 DB - PRIME DP - Unbound Medicine ER -