BETHESDA, Md. _ Anthony Fauci, director of the NationalInstitute of Allergy and Infectious Diseases (NIAID), on Mondaycalled for a better collaboration between federal AIDS researchersand vaccine manufacturers. In a speech to several hundred attendeesat the eighth annual conference on AIDS vaccine development, Fauciunveiled what he called the "optimal" strategic course in order to findan AIDS vaccine.

"My bring-home message today," said Fauci, is that the NationalInstitutes of Health (NIH) must strengthen its ties withmanufacturers." Fauci said he intends to foster "collaborativepartnerships" with vaccine makers "because we need a marriage ofresearch and empirical approaches."

According to NIAID's new strategic plan distributed at the meeting,the institute recently has changed the way it deals with manufacturersto negotiate specific ground rules that vaccines must meet in earlystages of testing. These prospectively negotiated agreements containconcept-specific milestones, options and decision-making criteria tobe applied at each decision point, according to the NAIAD plan.

Fauci stressed that "it is essential that the manufacturers not have amoving target." He pointed to the NIH's relationship with Biocine asan example of the improved Federal-industry partnership. Biocine,part of Chiron Inc., of Emeryville, Calif., is developing a "prime-plus-boost" protocol whereby individuals are immunized with acanary pox that is genetically engineered to express HIV proteins,followed by a booster of the same vaccine given together withrecombinant HIV envelope protein or an HIV core protein.

"We started negotiating with Biocene and their partners more thantwo years, " Fauci said. He explained that as the NIH considerswhether the vaccine manufacturer should be given the go-ahead toenter Phase II trials, it will be evaluated according to theprospectively-set milestones of establishing safety andimmunogenicity.

If the vaccine falls just short of one of these milestones, "we wouldgo back and re-negotiate," Fauci said.

Fauci said he recognized that there are many disincentives in themarketplace that discourage manufacturers from researching AIDSvaccines. However, "these disincentives are not insurmountable if thefederal government, academicians and industry collaborates," hesaid.

Fauci noted that many drug company executives attribute theirhesitancy about researching AIDS vaccines not to logistical issuesbut "scientific uncertainties." Fauci said the NIH needs to investigatethose scientific uncertainties so that industry feels less daunted.

AIDS Vaccine Development Is Unique

He noted that development of the AIDS vaccine differs markedlyfrom efforts to design other vaccines which confront diseases that arecommonly transmitted through the respiratory or gastro-intestinaltract. These other vaccines successfully protect against a disease thatis transmitted rarely or seasonally like the influenza while AIDS isassociated with behavioral patterns.

Manufacturers also face difficulties enrolling volunteers in clinicaltrials because they are concerned enrollment might increase their riskfor consequences in employment or social contact. Liability concernsalso dog manufacturers who anticipate they will be sued if a trialparticipant becomes infected with AIDS, Fauci said.

Overall, the NAIAD strategic plan described by Fauci included notonly better integration with manufacturers but also maintaining ascientific program that integrates fundamental research and empiricaldevelopment to advance a broad front of critical knowledge andvaccine designs, identifying and exploiting scientific opportunities toaccelerate HIV research, and to strengthen NIH's ties with the AIDScommunity. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.