Notice of Award of a Single Source Unsolicited Grant To Fund University of Southern Denmark (SDU)

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Disease Control and Prevention</SUBAGY> <SUBJECT>Notice of Award of a Single Source Unsolicited Grant To Fund University of Southern Denmark (SDU)</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $1,600,000 over a five-year period, in response to an unsolicited proposal that has been submitted by University of Southern Denmark (SDU). The award will support a comparable study of the optimal timing and delivery of monovalent Hepatitis B vaccinations on newborns in Guinea-Bissau. Activities will include conducting a randomized controlled trial to assess the effects of neonatal Hepatitis B vaccination on early-life mortality, morbidity, and long-term developmental outcomes. The award is in response to an unsolicited proposal. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The period for this award will be January 5, 2026, through January 4, 2031. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Sam Beyda, Office of the Director, Office of the Chief of Staff, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Atlanta, GA 30341, Telephone: (404) 404-639-7000, E-Mail: <E T="03">DirectorsIncoming@cdc.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> The proposed work being funded will support a single-blind, multi-center, phase IV randomized controlled trial enrolling over 14,000 neonates in Guinea-Bissau to evaluate the impact of neonatal monovalent Hepatitis B vaccination (HBV0) on all-cause mortality, severe morbidity, and long-term developmental outcomes. The study will also assess potential sex-differential effects of the vaccine. While the World Health Organization (WHO) recommends three vaccines at birth in low-income settings—Bacille Calmette Guérin (BCG), oral polio vaccine (OPV0), and HBV0—there is limited evidence on the broader health effects of HBV0. This study aims to fill that gap by rigorously evaluating the overall health impact of HBV0 in early life. CDC performed an objective review of the proposed work and determined, in accordance with its process for reviewing unsolicited proposals that the proposal has merit and that SDU is in a unique position to conduct this work, as it has extensive experience conducting vaccine trials in West Africa, established partnerships with local hospitals and health authorities in Guinea-Bissau, and a proven track record in neonatal and pediatric research in low-resource settings. The award is being made non-competitively because there is no current, pending, or planned funding opportunity announcement under which this proposal could compete. <HD SOURCE="HD1">Summary of the Award</HD> <E T="03">Recipient:</E> University of Southern Denmark (SDU). <E T="03">Purpose of the Award:</E> The purpose of this award is to evaluate the effects of neonatal monovalent Hepatitis B vaccination (HBV0) on early-life mortality and morbidity, as well as long-term neurodevelopmental outcomes, through a randomized controlled trial in Guinea-Bissau. The findings will inform global immunization policy and practice, particularly regarding the broader health effects of HBV0, which remain less well understood compared to BCG and OPV0. <E T="03">Amount of Award:</E> $1,600,000 in Federal Fiscal Year (FFY) 2026 funds, with the total estimated $1,600,000 provided for the full five-year period of performance, subject to availability of funds. <E T="03">Authority:</E> This program is authorized under the Public Health Service Act, Sections 301(a) [42 U.S.C. 241], 307 (42 U.S.C. 242l], and 317(k)(2) [42 U.S.C. 247b], as amended. <E T="03">Period of Performance:</E> January 5, 2026, through January 4, 2031. <SIG> <DATED>Dated: December 15, 2025.</DATED> <NAME>Jamie Legier,</NAME> Chief Grants Management Officer, Centers for Disease Control and Prevention. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-23245 Filed 12-17-25; 8:45 am]</FRDOC> </NOTICE>